Table of Contents

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 10-Q

 

 

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d)

OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended June 30, 2015

Commission File Number 1-6926

 

 

C. R. BARD, INC.

(Exact name of registrant as specified in its charter)

 

 

 

New Jersey  

730 Central Avenue

Murray Hill, New Jersey 07974

  22-1454160
(State of incorporation)  

(Address of principal

executive offices)

 

(I.R.S. Employer

Identification No.)

Registrant’s telephone number, including area code: (908) 277-8000

 

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.    Yes  x    No  ¨

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).    Yes  x    No  ¨

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer   x    Accelerated filer   ¨
Non-accelerated filer   ¨  (Do not check if smaller reporting company)    Smaller reporting company   ¨

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).    Yes  ¨    No  x

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date.

 

Class

   Outstanding at June 30, 2015

Common Stock - $0.25 par value

   74,199,143

 

 

 


Table of Contents

C. R. BARD, INC. AND SUBSIDIARIES

INDEX

 

         Page  

PART I – FINANCIAL INFORMATION

  

Item 1.

 

Financial Statements (unaudited)

  
 

Condensed Consolidated Statements of Operations for the Quarter and Six Months Ended June 30, 2015 and 2014

     3   
 

Condensed Consolidated Statements of Comprehensive (Loss) Income for the Quarter and Six Months Ended June 30, 2015 and 2014

     4   
 

Condensed Consolidated Balance Sheets – June 30, 2015 and December 31, 2014

     5   
 

Condensed Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2015 and 2014

     6   
 

Notes to Condensed Consolidated Financial Statements

     7   

Item 2.

 

Management’s Discussion and Analysis of Financial Condition and Results of Operations

     20   

Item 3.

 

Quantitative and Qualitative Disclosures About Market Risk

     30   

Item 4.

 

Controls and Procedures

     30   

PART II – OTHER INFORMATION

  

Item 1.

 

Legal Proceedings

     30   

Item 1A.

 

Risk Factors

     35   

Item 2.

 

Unregistered Sales of Equity Securities and Use of Proceeds

     35   

Item 5.

 

Other Information

     35   

Item 6.

 

Exhibits

     35   

Signatures

       36   

 

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PART I – FINANCIAL INFORMATION

Item 1. Financial Statements

C. R. BARD, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(dollars in thousands except per share amounts, unaudited)

 

     Quarter
Ended June 30,
    Six Months
Ended June 30,
 
     2015     2014     2015      2014  

Net sales

   $ 859,800      $ 827,100      $ 1,679,500       $ 1,626,400   

Costs and expenses:

         

Cost of goods sold

     333,700        320,700        644,900         630,200   

Marketing, selling and administrative expense

     250,000        245,200        485,700         482,000   

Research and development expense

     64,000        85,400        124,600         149,700   

Interest expense

     11,200        11,300        22,500         22,400   

Other (income) expense, net

     141,700        257,300        158,000         251,300   
  

 

 

   

 

 

   

 

 

    

 

 

 

Total costs and expenses

  800,600      919,900      1,435,700      1,535,600   
  

 

 

   

 

 

   

 

 

    

 

 

 

Income (loss) from operations before income taxes

  59,200      (92,800   243,800      90,800   

Income tax provision

  113,900      26,600      158,700      61,800   
  

 

 

   

 

 

   

 

 

    

 

 

 

Net (loss) income

$ (54,700 $ (119,400 $ 85,100    $ 29,000   
  

 

 

   

 

 

   

 

 

    

 

 

 

Basic (loss) earnings per share available to common shareholders

$ (0.74 $ (1.59 $ 1.13    $ 0.38   
  

 

 

   

 

 

   

 

 

    

 

 

 

Diluted (loss) earnings per share available to common shareholders

$ (0.74 $ (1.59 $ 1.11    $ 0.37   
  

 

 

   

 

 

   

 

 

    

 

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

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C. R. BARD, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE (LOSS) INCOME

(dollars in thousands, unaudited)

 

 

     Quarter
Ended June 30,
    Six Months
Ended June 30,
 
     2015     2014     2015     2014  

Net (loss) income

   $ (54,700   $ (119,400   $ 85,100      $ 29,000   

Other comprehensive income (loss):

        

Change in derivative instruments designated as cash flow hedges, net of tax

     3,800        1,300        3,900        1,700   

Foreign currency translation adjustments

     (10,900     2,400        (64,600     3,400   

Benefit plan adjustments, net of tax

     1,900        1,600        3,800        3,200   
  

 

 

   

 

 

   

 

 

   

 

 

 

Other comprehensive income (loss)

  (5,200   5,300      (56,900   8,300   
  

 

 

   

 

 

   

 

 

   

 

 

 

Comprehensive (loss) income

$ (59,900 $ (114,100 $ 28,200    $ 37,300   
  

 

 

   

 

 

   

 

 

   

 

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

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C. R. BARD, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(dollars in thousands except share and per share amounts, unaudited)

 

     June 30,
2015
    December 31,
2014
 

ASSETS

    

Current assets

    

Cash and cash equivalents

   $ 1,098,400      $ 960,100   

Restricted cash

     17,500        47,500   

Accounts receivable, less allowances of $8,400 and $10,100, respectively

     453,700        455,200   

Inventories

     383,600        376,200   

Short-term deferred tax assets

     126,600        93,300   

Other current assets

     93,300        114,800   
  

 

 

   

 

 

 

Total current assets

  2,173,100      2,047,100   
  

 

 

   

 

 

 

Property, plant and equipment, at cost

  786,000      747,900   

Less accumulated depreciation and amortization

  324,700      301,500   
  

 

 

   

 

 

 

Net property, plant and equipment

  461,300      446,400   

Goodwill

  1,079,700      1,091,200   

Core and developed technologies, net

  719,300      749,100   

Other intangible assets, net

  272,500      304,800   

Deferred tax assets

  14,700      11,500   

Other assets

  246,900      442,500   
  

 

 

   

 

 

 

Total assets

$ 4,967,500    $ 5,092,600   
  

 

 

   

 

 

 

LIABILITIES AND SHAREHOLDERS’ INVESTMENT

Current liabilities

Short-term borrowings and current maturities of long-term debt

$ 252,500    $ 78,000   

Accounts payable

  69,900      81,900   

Accrued expenses

  613,500      287,700   

Accrued compensation and benefits

  122,100      162,600   

Income taxes payable

  52,000      4,400   
  

 

 

   

 

 

 

Total current liabilities

  1,110,000      614,600   
  

 

 

   

 

 

 

Long-term debt

  1,147,500      1,401,900   

Other long-term liabilities

  876,800      1,125,300   

Deferred income taxes

  174,800      145,900   

Commitments and contingencies

Shareholders’ investment:

Preferred stock, $1 par value, authorized 5,000,000 shares; none issued

  —        —     

Common stock, $0.25 par value, authorized 600,000,000 shares; issued and outstanding 74,199,143 shares at June 30, 2015 and 74,893,483 shares at December 31, 2014

  18,500      18,700   

Capital in excess of par value

  2,041,700      1,945,300   

Accumulated deficit

  (256,100   (70,300

Accumulated other comprehensive loss

  (145,700   (88,800
  

 

 

   

 

 

 

Total shareholders’ investment

  1,658,400      1,804,900   
  

 

 

   

 

 

 

Total liabilities and shareholders’ investment

$ 4,967,500    $ 5,092,600   
  

 

 

   

 

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

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C. R. BARD, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(dollars in thousands, unaudited)

 

     Six Months
Ended June 30,
 
     2015     2014  

Cash flows from operating activities:

    

Net income

   $ 85,100      $ 29,000   

Adjustments to reconcile net income to net cash provided by operating activities:

    

Depreciation and amortization

     94,100        85,000   

Litigation charges, net

     346,000        262,700   

Restructuring and productivity initiative costs, net of payments

     7,300        —     

Asset impairment

     —          600   

Gain on sale of investment

     —          (7,100

Deferred income taxes

     (7,900     (19,500

Share-based compensation

     44,100        36,700   

Inventory reserves and provision for doubtful accounts

     9,500        10,400   

Other items

     2,600        1,100   

Changes in assets and liabilities:

    

Accounts receivable

     (1,100     31,000   

Inventories

     (33,000     (27,900

Current liabilities

     (90,100     (3,900

Taxes

     69,600        (112,800

Other, net

     (18,800     (1,300
  

 

 

   

 

 

 

Net cash provided by operating activities

  507,400      284,000   
  

 

 

   

 

 

 

Cash flows from investing activities:

Capital expenditures

  (57,600   (55,600

Change in restricted cash

  31,700      6,700   

Payments made for intangibles

  (400   (400

Proceeds from sale of investment

  —        7,100   
  

 

 

   

 

 

 

Net cash used in investing activities

  (26,300   (42,200
  

 

 

   

 

 

 

Cash flows from financing activities:

Change in short-term borrowings, net

  (78,000   181,500   

Proceeds from exercises under share-based compensation plans, net

  13,900      49,600   

Excess tax benefit relating to share-based compensation plans

  19,500      13,500   

Purchases of common stock

  (236,600   (526,100

Dividends paid

  (33,500   (32,700

Payments of contingent consideration

  (6,900   (200
  

 

 

   

 

 

 

Net cash used in financing activities

  (321,600   (314,400
  

 

 

   

 

 

 

Effect of exchange rate changes on cash and cash equivalents

  (21,200   1,800   
  

 

 

   

 

 

 

Increase (decrease) in cash and cash equivalents during the period

  138,300      (70,800
  

 

 

   

 

 

 

Balance at January 1

  960,100      1,066,900   
  

 

 

   

 

 

 

Balance at June 30

$ 1,098,400    $ 996,100   
  

 

 

   

 

 

 

Supplemental cash flow information

Cash paid for:

Interest

$ 21,400    $ 21,300   

Income taxes

  77,500      180,600   

Non-cash transactions:

Dividends declared, not paid

  18,100      16,700   

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

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C. R. BARD, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

1. Basis of Presentation

The accompanying unaudited condensed consolidated financial statements of C. R. Bard, Inc. and its subsidiaries (the “company” or “Bard”) should be read in conjunction with the audited consolidated financial statements and notes thereto included in Bard’s 2014 Annual Report on Form 10-K. These financial statements have been prepared on a basis that is substantially consistent with the accounting principles applied in the financial statements in Bard’s 2014 Annual Report on Form 10-K. The preparation of these financial statements requires the company to make estimates and judgments that affect reported amounts of assets, liabilities, revenues and expenses and the related disclosure of contingent assets and liabilities at the date of the financial statements. These financial statements include all normal and recurring adjustments necessary for a fair presentation. The accounts of most foreign subsidiaries are consolidated as of and for the quarters ended May 31, 2015 and May 31, 2014 and as of November 30, 2014. No events occurred related to these foreign subsidiaries during the months of May 2015, May 2014 or December 2014 that materially affected the financial position or results of operations of the company. The results for the interim periods presented are not necessarily indicative of the results expected for the year.

New Accounting Pronouncements Not Yet Adopted

In May 2014, the Financial Accounting Standards Board (the “FASB”) issued a new accounting standard that provides for a comprehensive model to use in the accounting for revenue arising from contracts with customers. Under this standard, revenue will be recognized to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. The FASB recently voted to defer this standard’s effective date for one year, which will now begin with Bard’s 2018 fiscal year. Early adoption is permitted as of the original effective date beginning with Bard’s 2017 fiscal year. The company continues to assess the new standard, as well as amendments to the standard that have been proposed by the FASB, and has not yet determined the adoption date or the impact to the consolidated financial statements.

2. Acquisition

On July 1, 2015, the company acquired all the outstanding shares of Vascular Pathways, Inc. (“VPI”), a privately-held developer and supplier of vascular access devices. VPI manufactures the AccuCath® Intravenous Catheter System, a United States Food and Drug Administration cleared device that enables rapid and safe peripheral intravenous (“PIV”) insertion. This acquisition allows the company to expand its wire-assist PIV technology platform to address unmet clinical needs and will supplement its intellectual property portfolio for wire-assist vascular access devices. The purchase consideration included an up-front cash payment of $89.9 million and future contingent payments of up to an additional $15 million based on specific revenue-based and manufacturing-related milestones. The company has not yet completed the initial purchase accounting due to the timing of this acquisition.

3. Earnings per Common Share

Earnings per share (“EPS”) is computed under the two-class method using the following common share information:

 

     Quarter Ended
June 30,
     Six Months
Ended June 30,
 
     2015      2014      2015      2014  

(dollars and shares in millions)

           

EPS Numerator:

           

Net (loss) income

   $ (54.7    $ (119.4    $ 85.1       $ 29.0   

Less: Income allocated to participating securities

     —           —           1.2         0.4   
  

 

 

    

 

 

    

 

 

    

 

 

 

Net (loss) income available to common shareholders

$ (54.7 $ (119.4 $ 83.9    $ 28.6   
  

 

 

    

 

 

    

 

 

    

 

 

 

EPS Denominator:

Weighted average common shares outstanding

  74.2      75.1      74.3      76.0   

Dilutive common share equivalents from share-based compensation plans

  —        —        1.4      1.5   
  

 

 

    

 

 

    

 

 

    

 

 

 

Weighted average common and common equivalent shares outstanding, assuming dilution

  74.2      75.1      75.7      77.5   
  

 

 

    

 

 

    

 

 

    

 

 

 

For the quarters ended June 30, 2015 and 2014, common share equivalents of approximately 1.3 million and 1.5 million, respectively, were not included in the computation of diluted weighted average shares outstanding. Common share equivalents primarily from share-based compensation plans were not included in these periods because their effect would have been anti-dilutive.

 

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C. R. BARD, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS—(Continued)

 

4. Income Taxes

The effective tax rate for the quarter and six months ended June 30, 2015 reflected the discrete tax effects of litigation charges, primarily related to product liability claims, which were substantially incurred in a low tax jurisdiction, and the gain related to the proceeds received from W. L. Gore & Associates, Inc. (“Gore”), which was incurred in a high tax jurisdiction. The effective tax rate for both the quarter and six months ended June 30, 2014 reflected the discrete tax effect of litigation charges, primarily related to product liability claims, which were substantially incurred in a low tax jurisdiction. See Note 7 of the notes to condensed consolidated financial statements. The effective tax rate for the six months ended June 30, 2014 also reflected a tax benefit of $10.9 million as a result of the completion of U.S. Internal Revenue Service examinations for the tax years 2008 through 2010.

At June 30, 2015, the total amount of liability for unrecognized tax benefits related to federal, state and foreign taxes was $34.6 million (of which $29.9 million would impact the effective tax rate, if recognized) plus $3.5 million of accrued interest. At December 31, 2014, the liability for unrecognized tax benefits was $36.1 million plus $2.9 million of accrued interest. Depending upon the result of open tax examinations and/or the expiration of applicable statutes of limitation, the company believes it is reasonably possible that the total amount of unrecognized tax benefits may decrease by up to $9.3 million within the next 12 months.

5. Financial Instruments

For further discussion regarding the company’s use of derivative instruments, see Note 1 of the notes to consolidated financial statements in Bard’s 2014 Annual Report on Form 10-K.

Foreign Exchange Derivative Instruments

The company enters into readily marketable forward and option contracts with financial institutions to help reduce its exposure to foreign currency exchange rate fluctuations. These contracts limit volatility because gains and losses associated with foreign currency exchange rate movements are generally offset by movements in the underlying hedged item. The notional value of the company’s forward currency and option currency contracts was $285.3 million and $191.1 million at June 30, 2015 and December 31, 2014, respectively.

Interest Rate Derivative Instruments

The company’s outstanding interest rate swap contract effectively converts its 2.875% fixed-rate notes due 2016 to a floating-rate instrument. The notional value of the company’s interest rate swap contract is $250 million.

The company’s outstanding forward starting interest rate swap contract manages its exposure to interest rate volatility in anticipation of issuing fixed-rate debt. The forward swap contract has a notional value of $250 million and a mandatory termination date of May 2016.

The location and fair value of derivative instruments that are designated as hedging instruments recognized in the condensed consolidated balance sheets are as follows:

 

     Balance Sheet
Location
   Fair Value
of Derivatives
 

Derivatives Designated as Hedging Instruments

      June 30,
2015
     December 31,
2014
 
(dollars in millions)                   

Forward currency contracts

   Other current assets    $ 1.9       $ 1.9   

Option currency contracts

   Other current assets      12.4         9.3   

Interest rate swap contracts

   Other current assets      5.0         —     

Forward currency contracts

   Other assets      0.2         —     

Option currency contracts

   Other assets      1.9         —     

Interest rate swap contracts

   Other assets      —           4.9   
     

 

 

    

 

 

 
$ 21.4    $ 16.1   
     

 

 

    

 

 

 

Forward currency contracts

Accrued expenses $ 5.3    $ 6.6   

Forward currency contracts

Other long-term liabilities   0.5      —     
     

 

 

    

 

 

 
$ 5.8    $ 6.6   
     

 

 

    

 

 

 

 

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Table of Contents

C. R. BARD, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS—(Continued)

 

The location and amounts of gains and losses on derivative instruments designated as cash flow hedges and the impact on shareholders’ investment are as follows:

 

     Gain/(Loss)
Recognized in Other
Comprehensive
Income (Loss)
     Location of
Gain/(Loss) Reclassified
from Accumulated
Other Comprehensive Loss into
Income
   Gain/(Loss) Reclassified
from Accumulated
Other Comprehensive Loss
into Income
 
     Quarter Ended
June 30,
        Quarter Ended
June 30,
 
     2015     2014         2015     2014  
(dollars in millions)                               

Forward currency contracts

   $ (1.9   $ 0.6       Cost of goods sold    $ (0.2   $ 0.2   

Option currency contracts

     1.4        0.6       Cost of goods sold      3.4        (0.4

Interest rate swap contract

     10.1        —         Interest expense      —          —     
  

 

 

   

 

 

       

 

 

   

 

 

 
$ 9.6    $ 1.2    $ 3.2    $ (0.2
  

 

 

   

 

 

       

 

 

   

 

 

 
     Gain/(Loss)
Recognized in Other
Comprehensive
Income (Loss)
     Location of
Gain/(Loss) Reclassified
from Accumulated
Other Comprehensive Loss into
Income
   Gain/(Loss) Reclassified
from Accumulated
Other Comprehensive Loss
into Income
 
     Six Months Ended
June 30,
        Six Months Ended
June 30,
 
     2015     2014         2015     2014  
(dollars in millions)                               

Forward currency contracts

   $ (1.8   $ 0.9       Cost of goods sold    $ 0.6      $ 0.8   

Option currency contracts

     10.4        —         Cost of goods sold      4.5        (1.0

Interest rate swap contract

     2.2        —         Interest expense      —          —     
  

 

 

   

 

 

       

 

 

   

 

 

 
$ 10.8    $ 0.9    $ 5.1    $ (0.2
  

 

 

   

 

 

       

 

 

   

 

 

 

The location and amounts of gains and losses on the derivative instrument designated as a fair value hedge are as follows:

 

     Location in
Statement of
Operations
     (Loss) Recognized on Swap     Gain Recognized on Debt  
        Quarter Ended
June 30,
    Six Months Ended
June 30,
    Quarter Ended
June 30,
     Six Months Ended
June 30,
 
        2015     2014     2015     2014     2015      2014      2015      2014  

(dollars in millions)

                      

Interest rate swap contract

     Interest expense       $ (1.1   $ (0.9   $ (2.1   $ (1.9   $ 1.1       $ 0.9       $ 2.1       $ 1.9   
     

 

 

   

 

 

   

 

 

   

 

 

   

 

 

    

 

 

    

 

 

    

 

 

 

Financial Instruments Measured at Fair Value on a Recurring Basis

Fair value is defined as the exit price that would be received to sell an asset or paid to transfer a liability. Fair value is a market-based measurement that is determined using assumptions that market participants would use in pricing an asset or liability. The fair value guidance establishes a three-level hierarchy which maximizes the use of observable inputs and minimizes the use of unobservable inputs used in measuring fair value. The levels within the hierarchy range from Level 1 having observable inputs to Level 3 having unobservable inputs.

The following table summarizes certain financial instrument assets and (liabilities) measured at fair value on a recurring basis:

 

     June 30,
2015
     December 31,
2014
 
(dollars in millions)              

Forward currency contracts

   $ (3.7    $ (4.7

Option currency contracts

     14.3         9.3   

Interest rate swap contracts

     5.0         4.9   

 

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C. R. BARD, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS—(Continued)

 

The fair values were measured using significant other observable inputs and valued by reference to similar financial instruments, adjusted for restrictions and other terms specific to each instrument. These financial instruments are categorized as Level 2 under the fair value hierarchy.

The fair value of the liability for contingent consideration related to acquisitions was $5.4 million and $23.1 million at June 30, 2015 and December 31, 2014, respectively. The decrease in the fair value of the liability for contingent consideration was primarily due to a reduction in the probability of the achievement of a certain revenue-based milestone and payment in respect of the achievement of unrelated milestones. The fair value was measured using significant unobservable inputs and is categorized as Level 3 under the fair value hierarchy.

Financial Instruments Not Measured at Fair Value

The company maintains a $750 million five-year committed syndicated bank credit facility that expires in November 2019. The credit facility supports the company’s commercial paper program and can be used for general corporate purposes. The facility includes pricing based on the company’s long-term credit ratings and includes a financial covenant that limits the amount of total debt to total capitalization. At June 30, 2015 the company was in compliance with this covenant. There were no commercial paper borrowings outstanding at June 30, 2015. The fair value of commercial paper borrowings outstanding of $78.0 million at December 31, 2014 approximated the carrying value.

The estimated fair value of long-term debt including current maturities and the effect of the related interest rate swap contract was approximately $1,469.9 million and $1,481.7 million at June 30, 2015 and December 31, 2014, respectively. The fair value was estimated using dealer quotes for similarly-rated debt instruments over the remaining contractual term of the company’s obligation and is categorized as Level 2 under the fair value hierarchy.

Concentration Risk

Accounts receivable balances include sales to government-supported healthcare systems outside the United States. The company monitors economic conditions and evaluates accounts receivable in certain countries for potential collection risks. Economic conditions and other factors in certain countries, particularly in Spain, Italy, Greece and Portugal, have resulted in, and may continue to result in, an increase in the average length of time that it takes to collect these accounts receivable and may require the company to re-evaluate the collectability of these receivables in future periods. At June 30, 2015, the company’s accounts receivable, net of allowances, from the national healthcare systems and private sector customers in these four countries was $52.8 million, of which $7.7 million was greater than 365 days past due.

The company is closely monitoring recent economic developments in Greece, including its financial stability and creditworthiness. At June 30, 2015, total accounts receivable, net of allowances, from both the national healthcare system and private sector customers in Greece was $12.6 million, of which $6.3 million was greater than 365 days past due.

6. Inventories

Inventories consisted of:

 

     June 30,
2015
     December 31,
2014
 
(dollars in millions)              

Finished goods

   $ 213.2       $ 225.4   

Work in process

     28.2         23.5   

Raw materials

     142.2         127.3   
  

 

 

    

 

 

 
$ 383.6    $ 376.2   
  

 

 

    

 

 

 

7. Contingencies

In the ordinary course of business, the company is subject to various legal proceedings, investigations and claims, including, for example, environmental matters, employment disputes, disputes on agreements and other commercial disputes. In addition, the company operates in an industry susceptible to significant product liability and patent legal claims. The company accounts for estimated losses with respect to legal proceedings and claims when such losses are probable and reasonably estimable. If the estimate of a probable loss is a range and no amount within the range is more likely, the company accrues the minimum amount of the range. Legal costs associated with these matters are expensed as incurred. At any given time, in the ordinary course of business, the company is involved as either a plaintiff or defendant in a number of patent infringement actions. If a third party’s patent infringement claim were to be determined against the company, the company might be required to make significant royalty or other payments or might be subject to an injunction or other limitation on its

 

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ability to manufacture or distribute one or more products. If a patent owned by or licensed to the company is found to be invalid or unenforceable, the company might be required to reduce the value of certain intangible assets on the company’s balance sheet and to record a corresponding charge, which could be significant in amount. Many of the company’s legal proceedings and claims could have a material adverse effect on its business, results of operations, financial condition and/or liquidity.

Product Liability Matters

Hernia Product Claims

As of July 1, 2015, approximately 45 federal and 40 state lawsuits involving individual claims by approximately 85 plaintiffs, as well as one putative class action in the United States, are currently pending against the company with respect to its Composix® Kugel® and certain other hernia repair implant products (collectively, the “Hernia Product Claims”). The company voluntarily recalled certain sizes and lots of the Composix® Kugel® products beginning in December 2005. As of July 1, 2015, all but one of the putative class actions pending against the company were dismissed. The remaining putative class action, which has not been certified, seeks: (i) medical monitoring; (ii) compensatory damages; (iii) punitive damages; (iv) a judicial finding of defect and causation; and/or (v) attorneys’ fees. In April 2014, a settlement was reached with respect to the three putative Canadian class actions within amounts previously recorded by the company. Approximately 25 of the state lawsuits, involving individual claims by approximately 25 plaintiffs, are pending in the Superior Court of the State of Rhode Island, with the remainder in various other jurisdictions. The Hernia Product Claims also generally seek damages for personal injury resulting from use of the products.

In June 2007, the Composix® Kugel® lawsuits and, subsequently, other hernia repair product lawsuits, pending in federal courts nationwide were transferred into one Multidistrict Litigation (“MDL”) for coordinated pre-trial proceedings in the United States District Court for the District of Rhode Island.

In June 2011, the company announced that it had reached agreements in principle with various plaintiffs’ law firms to settle the majority of its existing Hernia Product Claims. Each agreement was subject to certain conditions, including requirements for participation in the proposed settlements by a certain minimum number of plaintiffs. In addition, the company continues to engage in discussions with other plaintiffs’ law firms regarding potential resolution of unsettled Hernia Product Claims, and intends to vigorously defend Hernia Product Claims that do not settle, including through litigation. There are two trials currently scheduled in the second half of 2015. The company cannot give any assurances that the resolution of the Hernia Product Claims that have not settled, including asserted and unasserted claims and the putative class action lawsuit, will not have a material adverse effect on the company’s business, results of operations, financial condition and/or liquidity.

Women’s Health Product Claims

As of July 1, 2015, product liability lawsuits involving individual claims by approximately 15,260 plaintiffs have been filed against the company in various federal and state jurisdictions alleging personal injuries associated with the use of certain of the company’s surgical continence products for women. In addition, five putative class actions in the United States and five putative class actions in Canada have been filed against the company. In addition, a limited number of claims have been filed or asserted in various non-U.S. jurisdictions (all lawsuits, collectively, the “Women’s Health Product Claims”). The Women’s Health Product Claims generally seek damages for personal injury resulting from use of the products. The putative class actions, none of which has been certified, seek: (i) medical monitoring; (ii) compensatory damages; (iii) punitive damages; (iv) a judicial finding of defect and causation; and/or (v) attorneys’ fees. In April 2015, the Ontario Superior Court of Justice dismissed the plaintiffs’ motion for class certification in one Canadian putative class action. The plaintiffs may appeal this decision or may file an alternatives motion with the Ontario Superior Court to redefine the class. With respect to approximately half of the filed and asserted Women’s Health Product Claims, the company believes that two subsidiaries of Medtronic plc (as successor in interest to Covidien plc) (“Medtronic”), each a supplier of the company, have an obligation to defend and indemnify the company with respect to any product defect liability. As described below, in July 2015 the company reached an agreement with Medtronic regarding certain aspects of Medtronic’s indemnification obligation.

In October 2010, the Women’s Health Product Claims involving solely Avaulta® products pending in federal courts nationwide were transferred into an MDL in the United States District Court for the Southern District of West Virginia (the “District Court”), the scope of which was later expanded to include lawsuits involving all women’s surgical continence products that are manufactured or distributed by the company. The first trial in a state court was completed in California in July 2012 and resulted in a judgment against the company of approximately $3.6 million. On appeal the decision was affirmed by the appellate court in November 2014. The company filed a petition for review to the California Supreme Court on December 24, 2014, which was denied on February 18, 2015. The judgment in this matter, including interest and costs,

 

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was paid on March 20, 2015 within the amounts previously recorded by the company. The first trial in the MDL commenced in July 2013 and resulted in a judgment against the company of approximately $2 million. The company has appealed this decision. During the third quarter of 2013, the company settled one MDL case and one New Jersey state case. In addition, during the third quarter of 2013, one MDL case was voluntarily dismissed with prejudice. On January 16, 2014 and July 31, 2014, the District Court ordered that the company prepare 200 and then an additional 300 individual cases, respectively, for trial (the “WHP Pre-Trial Orders”) (the timing for which is currently unknown). The WHP Pre-Trial Orders resulted in significant additional litigation-related defense costs beginning in the second quarter of 2014 and continuing through the second quarter of 2015. In June 2015, the District Court issued an order staying the requirement to prepare a significant portion of the cases covered by the WHP Pre-Trial Orders. The WHP Pre-Trial Orders may result in material additional cost in the second half of 2015 in defending Women’s Health Product Claims. The District Court may also order that the company prepare additional cases for trial, which could result in material additional cost in future periods. During the second quarter of 2014, the company reached an agreement with two plaintiffs’ law firms to settle their inventory of cases, representing more than 500 of the filed or asserted Women’s Health Product Claims, which the company believes are not the subject of Medtronic’s indemnification obligation. The company also settled one MDL case that was originally scheduled for trial in May 2014. In the third quarter of 2014, the company reached an agreement with a plaintiffs’ law firm to settle approximately 25 of the filed or asserted Women’s Health Product Claims, which the company believes are not the subject of Medtronic’s indemnification obligation. The settlements reached in 2014 for Women’s Health Product Claims were within the amounts previously recorded by the company. In February 2015, the District Court appointed a Special Master to assist with settlement resolution. A trial was scheduled to begin in the MDL in February 2015, which the parties settled before trial. In June 2015, the company reached an agreement in principle with various plaintiffs’ law firms to settle their inventory of cases, representing more than 1,300 of the filed or asserted Women’s Health Product Claims. In July 2015, the company reached an agreement with various plaintiffs’ law firms to settle their inventory of cases, representing more than 1,500 of the filed or asserted Women’s Health Product Claims. Each agreement is subject to certain conditions, including requirements for participation in the proposed settlements by a certain minimum number of plaintiffs. In addition, the company continues to engage in discussions with other plaintiffs’ law firms regarding potential resolution of unsettled Women’s Health Product Claims, which may include additional inventory settlements. Notwithstanding these settlement efforts, the company anticipates that multiple additional trials, including one or more possible consolidated trials, may occur in 2015.

In December 2014, Medtronic filed a motion for leave to amend its answer in the underlying MDL for Women’s Health Product Claims to assert cross-claims against the company challenging the indemnification provisions of certain of their supply agreements with the company. In March 2015, the court granted Medtronic’s motion. On January 22, 2015, the company initiated litigation and/or arbitration seeking, among other things, declaratory relief under these supply agreements with Medtronic in three separate jurisdictions – New Jersey state court, the English High Court of Justice in London and Atlanta, Georgia. In July 2015, as part of the agreement noted above, Medtronic agreed to take responsibility for pursuing settlement of certain of the Women’s Health Product Claims that relate to products distributed by the company under supply agreements with Medtronic and the company agreed to pay Medtronic $121 million towards these potential settlements. The company also may, in its sole discretion, transfer responsibility for settlement of additional Women’s Health Product Claims to Medtronic on similar terms. The agreement does not resolve the dispute between the company and Medtronic with respect to Women’s Health Product Claims that do not settle, if any. As part of the agreement, Medtronic and the company agreed to dismiss without prejudice their pending litigation with respect to Medtronic’s obligation to defend and indemnify the company.

The company does not believe that any verdicts entered to date are representative of potential outcomes of all Women’s Health Product Claims. The case numbers set forth above do not include approximately 815 generic complaints involving women’s health products where the company cannot, based on the allegations in the complaints, determine whether any of those cases involve the company’s women’s health products. In addition, the case numbers set forth above do not include approximately 1,555 claims that have been threatened against the company but for which complaints have not yet been filed. While the company continues to engage in discussions with other plaintiffs’ law firms regarding potential resolution of unsettled Women’s Health Product Claims and intends to vigorously defend the Women’s Health Product Claims that do not settle, including through litigation, it cannot give any assurances that the resolution of these claims will not have a material adverse effect on the company’s business, results of operations, financial condition and/or liquidity.

Filter Product Claims

As of July 1, 2015, product liability lawsuits involving individual claims by approximately 50 plaintiffs are currently pending against the company in various federal and state jurisdictions alleging personal injuries associated with the use of the company’s vena cava filter products (all lawsuits, collectively, the “Filter Product Claims”). The first Filter Product Claim trial was completed in June 2012 and resulted in a judgment for the company. During the second quarter of 2013, the company finalized settlement agreements with respect to more than 30 Filter Product Claims and made payments with respect to such claims within the amounts previously recorded by the company. The case numbers set forth above do not

 

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include approximately 145 claims that have been threatened against the company but for which complaints have not yet been filed. The company expects additional trials of Filter Product Claims to take place over the next 12 months. While the company intends to vigorously defend Filter Product Claims that do not settle, including through litigation, it cannot give any assurances that the resolution of these claims will not have a material adverse effect on the company’s business, results of operations, financial condition and/or liquidity.

General

In most product liability litigations (like those described above), plaintiffs allege a wide variety of claims, ranging from allegations of serious injury caused by the products to efforts to obtain compensation notwithstanding the absence of any injury. In many of these cases, the company has not yet received and reviewed complete information regarding the plaintiffs and their medical conditions and, consequently, is unable to fully evaluate the claims. The company expects that it will receive and review additional information regarding any remaining unsettled product liability matters.

The company believes that some settlements and judgments, as well as some legal defense costs, relating to product liability matters are or may be covered in whole or in part under its product liability insurance policies with a limited number of insurance carriers, or, in some circumstances, indemnification obligations to the company from other parties. In certain circumstances, insurance carriers reserve their rights with respect to coverage, or contest or deny coverage, as has occurred with respect to certain claims. In addition, other parties may dispute their indemnification obligations to the company, as has occurred with respect to certain claims. When either of these occur, the company intends to vigorously contest disputes with respect to its insurance coverage or indemnification and to enforce its rights, and accordingly, will record expected recoveries with respect to amounts due under these policies or arrangements, when recovery is probable. Amounts recovered under the company’s product liability insurance policies or indemnification arrangements may be less than the stated coverage limits or less than otherwise expected and may not be adequate to cover damages and/or costs relating to claims. In addition, there is no guarantee that insurers or other parties will pay claims or that coverage or indemnity will be otherwise available.

The company’s insurance coverage with respect to the Hernia Product Claims has been exhausted. The company continues to evaluate its available insurance coverage as it relates to Women’s Health Product Claims and Filter Product Claims.

Other Legal Matters

Since early 2013, the company has received subpoenas or Civil Investigative Demands from a number of State Attorneys General seeking information related to the sales and marketing of certain of the company’s products that are the subject of the Hernia Product Claims and the Women’s Health Product Claims. The company is cooperating with these requests. Since it is not feasible to predict the outcome of these proceedings, the company cannot give any assurances that the resolution of these proceedings will not have a material adverse effect on the company’s business, results of operations, financial condition and/or liquidity.

In December 2007, a U.S. District Court jury in Arizona found that certain of Gore’s ePTFE vascular grafts and stent-grafts infringe the company’s patent number 6,436,135 (the “135 patent”). The jury upheld the validity of the company’s patent and awarded the company $185 million in past damages. The jury also found that Gore willfully infringed the patent. In a second phase of the trial, the District Court ruled that Gore failed to prove that the patent is unenforceable due to inequitable conduct. In March 2009, the District Court doubled the jury award to approximately $371 million for damages through June 2007. The District Court also awarded the company attorneys’ fees of $19 million and prejudgment interest of approximately $20 million. In addition, the District Court denied Gore’s remaining motions, including its motions for a new trial and to set aside the jury’s verdict. In July 2010, the District Court awarded the company approximately $109 million in additional damages for the period from July 2007 through March 2009. The District Court also assessed a royalty rate of between 12.5% and 20%, depending on the product, that is being used to calculate damages for Gore’s infringing sales from April 2009 through the expiration of the patent.

Gore appealed this matter to the Court of Appeals for the Federal Circuit (the “Court of Appeals”), which on February 10, 2012 affirmed the decision of the District Court. Gore filed a petition with the Court of Appeals for a rehearing of its appeal. On June 14, 2012, the Court of Appeals reaffirmed its February 10, 2012 decision, including the ongoing royalty rates as set by the District Court, with the exception of the issue of willfulness with respect to Gore’s infringement of the 135 patent, which was remanded to the District Court for further consideration. On October 12, 2012, Gore filed a petition for a writ of certiorari to the U.S. Supreme Court requesting a review of the portion of the decision that the Court of Appeals reaffirmed. The U.S. Supreme Court denied Gore’s petition on January 14, 2013.

On January 28, 2013, Gore filed with the District Court a Request for Judicial Notice that the U.S. Patent and Trademark Office (“USPTO”) granted Gore’s previously filed request for a re-examination of the 135 patent. On April 1,

 

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2013, the USPTO issued a First Office Action initially rejecting all of the claims of the 135 patent that are the subject of the re-examination. On July 10, 2013, the USPTO issued a Notice of Intent to Issue an Ex Parte Reexamination Certificate upholding the patentability of all re-examined claims of the 135 patent. This action terminated the re-examination proceeding and upheld the claims involved in the re-examination.

On remand of the action from the Court of Appeals, the District Court heard oral argument on June 5, 2013 on three motions pending before it – Gore’s motion requesting a determination that Gore’s infringement was not willful, Gore’s motion for a new trial, and the company’s motion to execute on the judgment with respect to all amounts other than enhanced damages due to willfulness. On October 16, 2013, the District Court denied Gore’s motion for entry of a judgment holding that Gore’s infringement was not willful and Gore’s motion for a new trial. The District Court granted the company’s motion to execute on the judgment, holding that all aspects of the judgment relating to infringement were “final and non-appealable.” The District Court continued its stay on the execution of the judgment with respect to willfulness and the related enhanced damages.

On November 1, 2013, Gore paid to the company $894.3 million in cash the total amount of the compensatory damages for infringement, including pre- and post-judgment interest, and the royalties accrued through September 30, 2013. Gore expressly reserved its right to appeal from the District Court’s rulings and notified the company that, if successful on appeal, it would seek to recover the amounts paid to the company. On December 5, 2013, Gore filed an appeal in the Court of Appeals on all of the District Court’s rulings, including the order denying Gore’s motion for a new trial. On August 8, 2014, the Court of Appeals heard oral argument on Gore’s appeal of the District Court’s rulings. On January 13, 2015, the Court of Appeals affirmed the decision of the District Court regarding its determination that the company established standing and that the 135 patent was willfully infringed. On February 12, 2015, Gore filed a petition for rehearing en banc at the Court of Appeals on the issue of willfulness. On April 8, 2015, the Court of Appeals denied Gore’s petition for rehearing en banc on the issue of willfulness. The company filed a motion to execute on the judgment on the issue of willfulness, which was granted by the District Court on April 23, 2015. On May 1, 2015, Gore paid to the company $210.5 million in cash, representing the total amount of the enhanced damages awarded by the District Court due to Gore’s willfulness and an audit adjustment related to the payment of royalties through September 30, 2013. Amounts received from Gore in May 2015 and previously in November 2013 are referred to as the “Gore Proceeds”. On July 7, 2015, Gore filed a petition for a writ of certiorari to the U.S. Supreme Court requesting a review of the decision that the 135 patent was infringed. The company believes Gore’s petition is without merit. Whether or not the Supreme Court will accept such petition, and the timing of such decision, is not known.

As of the third quarter of 2013, the company considered both the compensatory damages and the enhanced damages and the royalty awards to be contingent gains. In the fourth quarter of 2013, the company recorded a gain of $894.3 million ($557.4 million after tax) to other (income) expense, net, based on the District Court’s October 2013 rulings and the company’s receipt of the 2013 portion of the Gore Proceeds. In the second quarter of 2015, the company recorded a gain of $210.5 million ($131.7 million after tax) to other (income) expense, net, based on the District Court’s April 2015 ruling and the company’s receipt of the 2015 portion of the Gore Proceeds and an audit adjustment related to the payment of royalties through September 30, 2013. In April 2015, the company received $35.6 million of royalty payments from Gore representing Gore’s calculation of royalties for its infringing sales for the quarter ended March 31, 2015. This royalty payment and an audit adjustment of $1.3 million related to the payment of royalties from October 1, 2013 to March 31, 2015 were recorded to revenue in the second quarter of 2015. Royalty payments of $75.3 million were recorded to revenue for the six months ended June 30, 2015. The company has received cumulative proceeds from Gore of $1,331.9 million. The company has concluded that the chance of Gore establishing its right to recover any portion of the cumulative proceeds is remote.

The timing of final resolution of this litigation remains uncertain. The company cannot give any assurances that royalties for Gore’s future infringing sales will remain at or near historical levels.

In an unrelated matter, Gore filed suit in June 2011 in the U.S. District Court in Delaware alleging the company had infringed on several of Gore’s patents. Fact and expert discovery have been completed and in the fourth quarter of 2014, the parties both filed a number of motions, including motions for summary judgment. Oral arguments on the motions occurred on January 30, 2015. In June 2015, the Magistrate Judge of the Delaware District Court issued a preliminary ruling on three of these motions, granting the company’s motion for summary judgment on non-infringement of one of Gore’s patents and denying the company’s motions for summary judgment for patent invalidity due to the patents being indefinite and to exclude expert testimony of Gore’s technical expert. The rulings remain subject to the final approval of the Delaware District Court. The company intends to vigorously defend the allegations asserted by Gore. The company cannot give any assurances that an adverse resolution of this matter will not have a material adverse effect on the company’s business, results of operations, financial condition and/or liquidity.

 

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The company is subject to numerous federal, state, local and foreign environmental protection laws governing, among other things, the generation, storage, use and transportation of hazardous materials and emissions or discharges into the ground, air or water. The company is or may become a party to proceedings brought under various federal laws including the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA), commonly known as Superfund, the Resource Conservation and Recovery Act, the Clean Water Act, the Clean Air Act and similar state or foreign laws. These proceedings seek to require the owners or operators of contaminated sites, transporters of hazardous materials to the sites and generators of hazardous materials disposed of at the sites to clean up the sites or to reimburse the government for cleanup costs. In most cases, there are other potentially responsible parties that may be liable for remediation costs. In these cases, the government alleges that the defendants are jointly and severally liable for the cleanup costs; however, these proceedings are frequently resolved so that the allocation of cleanup costs among the parties more closely reflects the relative contributions of the parties to the site contamination. The company’s potential liability varies greatly from site to site. For some sites, the potential liability is de minimis and for others the costs of cleanup have not yet been determined. Accruals for estimated losses from environmental remediation obligations generally are recognized no later than completion of the remedial feasibility study and are adjusted as further information develops or circumstances change. Costs of future expenditures for environmental remediation obligations are not discounted to their present value. Recoveries of environmental remediation costs from other parties are recorded as assets when their receipt is deemed probable. The company believes that the proceedings and claims described above will likely be resolved over an extended period of time. While it is not feasible to predict the outcome of these proceedings, based upon the company’s experience, current information and applicable law, the company does not expect these proceedings to have a material adverse effect on its financial condition and/or liquidity. However, one or more of the proceedings could be material to the company’s business and/or results of operations.

Litigation Reserves

The company regularly monitors and evaluates the status of product liability and other legal matters, and may, from time-to-time, engage in settlement and mediation discussions taking into consideration developments in the matters and the risks and uncertainties surrounding litigation. These discussions could result in settlements of one or more of these claims at any time.

In the second quarter of 2013, the company recorded a charge, net of estimated recoveries to other (income) expense, net, of approximately $293.0 million ($276.0 million after tax) related to certain of the product liability matters discussed above under the heading “Product Liability Matters”. The company recorded this charge after evaluating these matters based on information then currently available, including but not limited to: the allegations and documentation supporting or refuting such allegations; publicly available information regarding similar medical device mass tort settlements; historical information regarding other product liability settlements involving the company; and the procedural posture and stage of litigation. In the fourth quarter of 2013, based on information then available regarding these and other factors, including but not limited to: the increase in the number of claims; the estimate of unasserted claims; the settlement of claims both by the company and by other manufacturers subject to product liability claims with respect to similar products; and settlements subject to negotiation during the quarter, the company recorded an additional charge, net of estimated recoveries, of approximately $108.0 million ($92.0 million after tax).

In the second quarter of 2014, the company recorded an additional charge related to these matters, net of estimated recoveries to other (income) expense, net, of approximately $259.0 million ($238.0 million after tax). The company recorded this charge based on additional information obtained during the quarter, including with respect to the factors noted above. Specifically, the company considered its discussions with plaintiffs’ counsel, the increase in the rate of claims being filed (which led the company to increase its estimate of unasserted claims), and the value, number of cases and nature of the inventory of cases with respect to the recent settlements of claims by the company and other manufacturers.

In the second quarter of 2015, the company recorded an additional charge related to these matters, net of estimated recoveries to other (income) expense, net, of approximately $337.0 million ($325.0 million after tax). The company recorded this charge based on additional information obtained during the quarter, including with respect to the factors noted above. Specifically the company considered the agreement and the agreement in principle by the company to settle more than 2,800 filed or asserted Women’s Health Product Claims, the involvement of the Special Master in settlement resolution, additional settlements by other manufacturers subject to product liability claims with respect to similar products, and the continued rate of claims being filed (which led the company to increase its estimate of unasserted claims).

These charges recognized the estimated costs for the product liability matters discussed above, including (with respect to such matters) asserted and unasserted claims, and costs to administer the settlements related to such matters. These charges exclude any costs associated with the putative class action lawsuits in the United States.

 

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The company cannot give any assurances that the actual costs incurred with respect to these product liability matters will not exceed the related amounts accrued. With respect to product liability claims that are not resolved through settlement, the company intends to vigorously defend against such claims, including through litigation. The company cannot give any assurances that the resolution of any of its product liability matters, including asserted and unasserted claims and the putative class action lawsuits, will not have a material adverse effect on the company’s business, results of operations, financial condition and/or liquidity.

Accruals for product liability and other legal matters amounted to $1,139.0 million, of which $445.7 million was recorded to accrued expenses, and $1,041.5 million, of which $101.7 million was recorded to accrued expenses, at June 30, 2015 and December 31, 2014, respectively. The company has made total payments of $249.5 million to qualified settlement funds (“QSFs”), subject to certain settlement conditions, for certain product liability matters. No payments were made to QSFs during the six months ended June 30, 2015. Payments to QSFs are recorded as a component of restricted cash. Total payments of $234.1 million from these QSFs have been made to qualified claimants, of which $32.1 million were made during the six months ended June 30, 2015. In addition, other payments of $54.2 million have been made to qualified claimants, of which $13.5 million were made during the six months ended June 30, 2015.

The company recorded expected recoveries related to product liability matters amounting to $174.7 million, of which $155.2 million was recorded to other assets, and $379.3 million, of which $358.9 million was recorded to other assets, at June 30, 2015 and December 31, 2014, respectively. A substantial amount of these recoveries at December 31, 2014 were the subject of a dispute with Medtronic, which had contested, at least in part, its obligation to defend and indemnify the company. The decrease in expected recoveries is primarily due to the agreement with Medtronic entered into in July 2015 regarding certain aspects of Medtronic’s indemnification obligation. The terms of the company’s agreement with Medtronic are substantially consistent with the assumptions underlying, and the manner in which, the company has recorded expected recoveries related to the indemnification obligation. The expected recoveries at June 30, 2015 related to the indemnification obligation are not in dispute with respect to claims that Medtronic settles pursuant to the agreement. As described above, the agreement does not resolve the dispute between the company and Medtronic with respect to Women’s Health Product Claims that do not settle, if any, and the company also may, in its sole discretion, transfer responsibility for settlement of additional Women’s Health Product Claims to Medtronic on similar terms.

The company had previously engaged outside counsel to evaluate the company’s rights with respect to Medtronic’s indemnification obligation, and outside counsel issued a legal opinion supporting the company’s belief regarding Medtronic’s obligation to defend and indemnify the company for product defect claims with respect to the products manufactured by Medtronic that are the subject of the Women’s Health Product Claims. After considering the following factors (as appropriate): the nature of the claims; relevant contracts; relevant factual and legal issues; the advice and judgment of outside legal counsel, including a legal opinion; the agreement with Medtronic; the creditworthiness of Medtronic; and other pertinent factors, as of June 30, 2015, the company believed that these expected recoveries were probable and therefore have been recorded as an asset.

The company is unable to estimate the reasonably possible losses or range of losses, if any, arising from certain existing product liability matters and other legal matters. Under U.S. generally accepted accounting principles, an event is “reasonably possible” if “the chance of the future event or events occurring is more than remote but less than likely” and an event is “remote” if “the chance of the future event or events occurring is slight”. With respect to putative class action lawsuits in the United States relating to product liability matters, the company is unable to estimate a range of reasonably possible losses for the following reasons: (i) all or certain of the proceedings are in early stages; (ii) the company has not received and reviewed complete information regarding all or certain of the plaintiffs and their medical conditions; and/or (iii) there are significant factual issues to be resolved. In addition, there is uncertainty as to the likelihood of a class being certified or the ultimate size of the class. In addition, with respect to the Civil Investigative Demands from a number of State Attorneys General, the company is unable to estimate a range of reasonably possible losses for the following reasons: (i) all or certain of the proceedings are in early stages; and/or (ii) there are significant factual issues to be resolved.

8. Share-Based Compensation Plans

The company may grant a variety of share-based payments under the 2012 Long Term Incentive Plan of C. R. Bard, Inc., as amended and restated (the “LTIP”) and the 2005 Directors’ Stock Award Plan of C. R. Bard, Inc., as amended and restated (the “Directors’ Plan”) to certain directors, officers and employees. At the company’s Annual Meeting of Shareholders on April 15, 2015, the shareholders authorized an additional 1,500,000 shares for issuance under the LTIP. The total number of remaining shares at June 30, 2015 that may be issued under the LTIP was 6,290,425 and under the Directors’ Plan was 31,462. Awards under the LTIP may be in the form of stock options, stock appreciation rights, limited stock appreciation rights, restricted stock, unrestricted stock and other stock-based awards. Awards under the Directors’ Plan may be in the form of stock awards, stock options or stock appreciation rights. The company also has two employee stock purchase programs.

 

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C. R. BARD, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS—(Continued)

 

For the quarters ended June 30, 2015 and 2014, amounts charged against income for share-based payment arrangements were $21.1 million and $17.2 million, respectively. For the six months ended June 30, 2015 and 2014, amounts charged against income for share-based payment arrangements were $44.1 million and $36.7 million, respectively.

In the first quarter of each of 2015 and 2014, the company granted performance restricted stock units to certain officers. These units have requisite service periods of three years and have no dividend rights. The actual payout of these units varies based on the company’s performance over the three-year period based on pre-established targets over the period and a market condition modifier based on total shareholder return (“TSR”) compared to an industry peer group. The actual payout under these awards may exceed an officer’s target payout; however, compensation cost initially recognized assumes that the target payout level will be achieved and may be adjusted for subsequent changes in the expected outcome of the performance-related condition. The fair values of these units are based on the market price of the company’s stock on the date of the grant and use a Monte Carlo simulation model for the TSR component. The fair values of the TSR components of the 2015 and 2014 grants were estimated based on the following assumptions: risk-free interest rate of 0.86% and 0.70%, respectively; dividend yield of 0.51% and 0.62%, respectively; and expected life of 2.78 and 2.88 years, respectively.

As of June 30, 2015, there were $100.9 million of unrecognized compensation expenses related to share-based payment arrangements. These costs are expected to be recognized over a weighted-average period of approximately three years. The company has sufficient shares to satisfy expected share-based payment arrangements in 2015.

9. Pension Plans

The company has both tax-qualified and nonqualified, noncontributory defined benefit pension plans, that together cover certain domestic and foreign employees. These plans provide benefits based upon a participant’s compensation and years of service.

The components of net periodic pension cost are as follows:

 

     Quarter Ended
June 30,
     Six Months Ended
June 30,
 
     2015      2014      2015      2014  
(dollars in millions)              

Service cost, net of employee contributions

   $ 7.5       $ 6.8       $ 15.0       $ 13.5   

Interest cost

     4.9         5.2         9.9         10.5   

Expected return on plan assets

     (7.8      (6.8      (15.6      (13.6

Amortization

     2.9         2.5         5.8         4.9   
  

 

 

    

 

 

    

 

 

    

 

 

 

Net periodic pension cost

$ 7.5    $ 7.7    $ 15.1    $ 15.3   
  

 

 

    

 

 

    

 

 

    

 

 

 

10. Shareholders’ Investment

The company repurchased approximately 1.4 million shares of common stock for $236.6 million in the six months ended June 30, 2015 under its previously announced share repurchase authorizations.

Other Comprehensive Income (Loss)

The changes in accumulated other comprehensive income (loss) by component are as follows:

 

    Derivative
Instruments
Designated as
Cash Flow Hedges
    Foreign Currency
Translation
Adjustments
    Benefit
Plans
    Total  
(dollars in millions)                        

Balance at December 31, 2013

  $ —        $ 47.3      $ (68.2   $ (20.9

Other comprehensive income (loss) before reclassifications

    1.6        3.4        —          5.0   

Tax (provision) benefit related to other comprehensive income (loss) before reclassifications(a)

    0.4        —          —          0.4   
 

 

 

   

 

 

   

 

 

   

 

 

 

 

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C. R. BARD, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS—(Continued)

 

    Derivative
Instruments
Designated as
Cash Flow Hedges
    Foreign Currency
Translation
Adjustments
    Benefit
Plans
    Total  
(dollars in millions)                        

Other comprehensive income (loss) before reclassifications, net of taxes

    2.0        3.4        —          5.4   
 

 

 

   

 

 

   

 

 

   

 

 

 

Amounts reclassified from accumulated other comprehensive income (loss)

  0.2 (b)    —        4.9 (c)    5.1   

Tax provision (benefit) related to amounts reclassified from accumulated other comprehensive income (loss)

  (0.5   —        (1.7   (2.2
 

 

 

   

 

 

   

 

 

   

 

 

 

Reclassifications, net of tax

  (0.3   —        3.2      2.9   
 

 

 

   

 

 

   

 

 

   

 

 

 

Other comprehensive income (loss)

  1.7      3.4      3.2      8.3   
 

 

 

   

 

 

   

 

 

   

 

 

 

Balance at June 30, 2014

$ 1.7    $ 50.7    $ (65.0 $ (12.6
 

 

 

   

 

 

   

 

 

   

 

 

 

Balance at December 31, 2014

$ 0.9    $ (3.1 $ (86.6 $ (88.8

Other comprehensive income (loss) before reclassifications

  10.0      (64.6   —        (54.6

Tax (provision) benefit related to other comprehensive income (loss) before reclassifications(a)

  (2.4   —        —        (2.4
 

 

 

   

 

 

   

 

 

   

 

 

 

Other comprehensive income (loss) before reclassifications, net of taxes

  7.6      (64.6   —        (57.0
 

 

 

   

 

 

   

 

 

   

 

 

 

Amounts reclassified from accumulated other comprehensive income (loss)

  (5.1 )(b)    —        5.8 (c)    0.7   

Tax provision (benefit) related to amounts reclassified from accumulated other comprehensive income (loss)

  1.4      —        (2.0   (0.6
 

 

 

   

 

 

   

 

 

   

 

 

 

Reclassifications, net of tax

  (3.7   —        3.8      0.1   
 

 

 

   

 

 

   

 

 

   

 

 

 

Other comprehensive income (loss)

  3.9      (64.6   3.8      (56.9
 

 

 

   

 

 

   

 

 

   

 

 

 

Balance at June 30, 2015

$ 4.8    $ (67.7 $ (82.8 $ (145.7
 

 

 

   

 

 

   

 

 

   

 

 

 

 

(a) Income taxes are not provided for foreign currency translation adjustment.
(b) See Note 5 of the notes to condensed consolidated financial statements.
(c) These components are included in the computation of net periodic pension cost. See Note 9 of the notes to condensed consolidated financial statements.

11. Segment Information

The company’s management considers its business to be a single segment entity – the manufacture and sale of medical devices. The company’s products generally share similar distribution channels and customers. The company designs, develops, manufactures, packages, distributes and sells medical, surgical, diagnostic and patient care devices. The company sells a broad range of products to hospitals, individual healthcare professionals, extended care health facilities and alternate site facilities on a global basis. In general, the company’s products are intended to be used once and then discarded or either temporarily or permanently implanted. The company’s chief operating decision makers evaluate their various global product portfolios on a net sales basis and generally evaluate profitability and associated investment on an enterprise-wide basis due to shared geographic infrastructures.

 

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C. R. BARD, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS—(Continued)

 

Net sales based on the location of external customers by geographic region are:

 

     Quarter Ended
June 30,
     Six Months Ended
June 30,
 
     2015      2014      2015      2014  
(dollars in millions)                            

United States

   $ 592.0       $ 555.1       $ 1,166.1       $ 1,106.5   

Europe

     108.8         126.4         215.2         246.5   

Japan

     43.2         42.3         84.2         81.2   

Other

     115.8         103.3         214.0         192.2   
  

 

 

    

 

 

    

 

 

    

 

 

 
$ 859.8    $ 827.1    $ 1,679.5    $ 1,626.4   
  

 

 

    

 

 

    

 

 

    

 

 

 

Total net sales by product group category are:

 

     Quarter Ended
June 30,
     Six Months Ended
June 30,
 
     2015      2014      2015      2014  
(dollars in millions)                            

Vascular

   $ 248.6       $ 233.0       $ 480.5       $ 452.2   

Urology

     209.2         207.1         414.8         408.5   

Oncology

     235.2         224.7         459.8         443.7   

Surgical Specialties

     143.8         139.3         279.7         274.5   

Other

     23.0         23.0         44.7         47.5   
  

 

 

    

 

 

    

 

 

    

 

 

 
$ 859.8    $ 827.1    $ 1,679.5    $ 1,626.4   
  

 

 

    

 

 

    

 

 

    

 

 

 

 

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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

This management’s discussion and analysis provides a review of the results of operations, financial condition and the liquidity and capital resources of C. R. Bard, Inc. and its subsidiaries (the “company” or “Bard”). The following discussion should be read in conjunction with Bard’s 2014 Annual Report on Form 10-K, and the condensed consolidated financial statements and notes thereto included elsewhere in this Form 10-Q. Certain statements contained herein may contain forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995; see “Risks and Uncertainties; Cautionary Statement Regarding Forward-Looking Information” below.

Overview

The company designs, develops, manufactures, packages, distributes and sells medical, surgical, diagnostic and patient care devices. The company sells a broad range of products to hospitals, individual healthcare professionals, extended care health facilities and alternate site facilities on a global basis. Outside the United States, Europe, Japan and China are the company’s largest markets, while certain emerging markets in Asia, Latin America, and Eastern Europe are the company’s fastest-growing markets. In general, the company’s products are intended to be used once and then discarded or either temporarily or permanently implanted. The company reports sales in four major product group categories: vascular; urology; oncology; and surgical specialties. The company also has a product group category of other products.

The company’s earnings are driven by its ability to continue to generate sales of its products and improve operating efficiency. Bard’s ability to increase sales over time depends upon its success in developing, acquiring and marketing differentiated products that meet the needs of clinicians and their patients. For the six months ended June 30, 2015, the company’s research and development (“R&D”) expense as a percentage of net sales was 7.4%. The company also makes selective acquisitions of businesses, products and technologies, generally focusing on small-to-medium sized transactions to provide ongoing growth opportunities. In addition, the company may from time-to-time consider acquisitions of larger, established companies. The company may also periodically divest lines of business in which it is not able to reasonably attain or maintain a leadership position in the market or for other strategic reasons.

Acquisition and Legal Developments

Acquisition

On July 1, 2015, the company acquired all the outstanding shares of Vascular Pathways, Inc. (“VPI”), a privately-held developer and supplier of vascular access devices. The purchase consideration included an up-front cash payment of $89.9 million and future contingent payments of up to an additional $15 million based on specific revenue-based and manufacturing-related milestones. The purchase of VPI was funded by a combination of available cash and short-term borrowings. See Note 2 of the notes to condensed consolidated financial statements.

Legal Developments

In connection with the company’s ongoing suit against W. L. Gore & Associates, Inc. (“Gore”) for infringing Bard’s patent number 6,436,135, the company filed a motion to execute on the judgment on the issue of willfulness, which was granted by the U.S. District Court for the District of Arizona on April 23, 2015. On May 1, 2015, Gore paid the company $210.5 million in cash, representing the total amount of the enhanced damages awarded by this District Court due to Gore’s willfulness and an audit adjustment related to the payment of royalties through September 30, 2013. Amounts received from Gore in May 2015 and previously in November 2013 are referred to as the “Gore Proceeds”. In the second quarter of 2015, the company recorded a gain of $210.5 million ($131.7 million after tax) to other (income) expense, net, based on this District Court’s April 23, 2015 ruling and the company’s receipt of the May 2015 portion of the Gore Proceeds.

In the second quarter of 2015, the company recorded an additional charge related to product liability matters, net of estimated recoveries, to other (income) expense, net, of approximately $337.0 million ($325.0 million after tax).

For more information on legal matters, see Note 7 of the notes to condensed consolidated financial statements.

Results of Operations

Net Sales

Bard’s consolidated net sales for the quarter ended June 30, 2015 increased 4% on a reported basis (8% on a constant currency basis) compared to the same period in the prior year. Bard’s consolidated net sales for the six months ended June 30, 2015 increased 3% on a reported basis (7% on a constant currency basis) compared to the same period in the prior year. Net sales “on a constant currency basis” is a non-GAAP measure and should not be viewed as a replacement of GAAP results. See “Management’s Use of Non-GAAP Measures” below. Price changes had the effect of decreasing consolidated

 

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net sales for the quarter and six months ended June 30, 2015 by approximately 120 basis points and 130 basis points, respectively, as compared to the same periods in the prior year. The strengthening of the U.S. dollar, a trend that may continue, had the effect of decreasing consolidated net sales by approximately four percentage points for both the quarter and six months ended June 30, 2015 as compared to the same periods in the prior year. The primary exchange rate fluctuation that impacted net sales was the movement of the Euro compared to the U.S. dollar. The impact of exchange rate fluctuations on net sales is not indicative of the impact on net earnings due to the offsetting impact of exchange rate movements on operating costs and expenses, costs incurred in other currencies and the company’s hedging activities.

Bard’s United States net sales of $592.0 million for the quarter ended June 30, 2015 increased 7% compared to $555.1 million in the prior year quarter. International net sales of $267.8 million for the quarter ended June 30, 2015 decreased 2% on a reported basis (increased 11% on a constant currency basis) compared to $272.0 million in the prior year quarter. Bard’s United States net sales of $1,166.1 million for the six months ended June 30, 2015 increased 5% compared to $1,106.5 million in the prior year period. International net sales of $513.4 million for the six months ended June 30, 2015 decreased 1% on a reported basis (increased 9% on a constant currency basis) compared to $519.9 million in the prior year period.

A summary of net sales by product group category is as follows:

Product Group Summary of Net Sales

 

     Quarter Ended June 30,     Six Months Ended June 30,  
     2015      2014      Change     Constant
Currency
    2015      2014      Change     Constant
Currency
 
(dollars in millions)                                        

Vascular

   $ 248.6       $ 233.0         7     12   $ 480.5       $ 452.2         6     11

Urology

     209.2         207.1         1     4     414.8         408.5         2     4

Oncology

     235.2         224.7         5     8     459.8         443.7         4     6

Surgical Specialties

     143.8         139.3         3     6     279.7         274.5         2     5

Other

     23.0         23.0         —          2     44.7         47.5         (6 )%      (4 )% 
  

 

 

    

 

 

        

 

 

    

 

 

      

Total net sales

$ 859.8    $ 827.1      4   8 $ 1,679.5    $ 1,626.4      3   7
  

 

 

    

 

 

        

 

 

    

 

 

      

Vascular Products - Bard markets a wide range of products for the peripheral vascular market, including endovascular products and vascular graft products. Also included within vascular products are royalty payments from Gore. Consolidated net sales of vascular products for the quarter ended June 30, 2015 increased 7% on a reported basis (12% on a constant currency basis) compared to the prior year quarter. Consolidated net sales of vascular products for the six months ended June 30, 2015 increased 6% on a reported basis (11% on a constant currency basis) compared to the prior year period. These increases were primarily due to growth in sales of endovascular products. United States net sales of vascular products for the quarter ended June 30, 2015 increased 13% compared to the prior year quarter. International net sales of vascular products for the quarter ended June 30, 2015 decreased 4% on a reported basis (increased 11% on a constant currency basis) compared to the prior year quarter. United States net sales of vascular products for the six months ended June 30, 2015 increased 11% compared to the prior year period. International net sales of vascular products for the six months ended June 30, 2015 decreased 1% on a reported basis (increased 11% on a constant currency basis) compared to the prior year period.

Consolidated net sales of endovascular products for the quarter ended June 30, 2015 increased 8% on a reported basis (13% on a constant currency basis) compared to the prior year quarter. Consolidated net sales of endovascular products for the six months ended June 30, 2015 increased 7% on a reported basis (12% on a constant currency basis) compared to the prior year period. Net sales in this product line for both the quarter and six months ended June 30, 2015 were favorably impacted by growth in sales of percutaneous transluminal angioplasty (“PTA”) balloon catheters, including drug-coated PTA balloon catheters, and biopsy products, and were partially offset by declines in sales of stents, a trend that may continue.

Consolidated net sales of vascular graft products for the quarter ended June 30, 2015 decreased 12% on a reported basis (5% on a constant currency basis) compared to the prior year quarter. Consolidated net sales of vascular graft products for the six months ended June 30, 2015 decreased 11% on a reported basis (4% on a constant currency basis) compared to the prior year period. Declining sales of peripheral vascular grafts was the primary contributor to the decreases in sales for vascular graft products for both the quarter and six months ended June 30, 2015.

Urology Products - Bard markets a wide range of products for the urology market, including basic urology drainage products, fecal and urinary continence products and urological specialty products. Bard also markets StatLock® catheter stabilization products, which are used to secure many types of catheters sold by Bard and other companies, as well as Targeted Temperature Management™ products, which are used for therapeutic hypothermia. Consolidated net sales of urology products for the quarter ended June 30, 2015 increased 1% on a reported basis (4% on a constant currency basis) compared to the prior year quarter. Consolidated net sales of urology products for the six months ended June 30, 2015 increased 2% on a

 

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reported basis (4% on a constant currency basis) compared to the prior year period. These increases were primarily due to growth in sales of basic drainage products and Targeted Temperature Management™ products and were partially offset by declines in sales of surgical continence products, a trend that may continue. United States net sales of urology products for both the quarter and six months ended June 30, 2015 increased 4% compared to the prior year periods. International net sales of urology products for the quarter ended June 30, 2015 decreased 4% on a reported basis (increased 6% on a constant currency basis) compared to the prior year quarter. International net sales of urology products for the six months ended June 30, 2015 decreased 3% on a reported basis (increased 6% on a constant currency basis) compared to the prior year period. International net sales for the quarter and six months ended June 30, 2015 reflected declines in sales of surgical continence products and Targeted Temperature Management™ products.

Consolidated net sales of basic drainage products for the quarter ended June 30, 2015 increased 2% on a reported basis (3% on a constant currency basis) compared to the prior year quarter. Consolidated net sales of basic drainage products for the six months ended June 30, 2015 increased 2% on a reported basis (4% on a constant currency basis) compared to the prior year period.

Consolidated net sales of urological specialty products for the quarter ended June 30, 2015 decreased 3% on a reported basis (increased 3% on a constant currency basis) compared to the prior year quarter. Consolidated net sales of urological specialty products for the six months ended June 30, 2015 decreased 4% on a reported basis (increased 1% on a constant currency basis) compared to the prior year period. These decreases were primarily due to declines in sales of brachytherapy products. The brachytherapy market has been losing procedural share to alternative therapies, a trend that may continue.

Consolidated net sales of continence products for the quarter ended June 30, 2015 decreased 7% on a reported basis (increased 4% on a constant currency basis) compared to the prior year quarter. Consolidated net sales of continence products for the six months ended June 30, 2015 decreased 3% on a reported basis (increased 5% on a constant currency basis) compared to the prior year period. These decreases were primarily due to declines in sales of surgical continence products, a trend that may continue. The decrease for the six months ended June 30, 2015 was partially offset by an increase in sales of fecal continence products.

Consolidated net sales of the StatLock® catheter stabilization product line for the quarter ended June 30, 2015 were flat on a reported basis (increased 2% on a constant currency basis) compared to the prior year quarter. Consolidated net sales of the StatLock® catheter stabilization product line for the six months ended June 30, 2015 increased 1% on a reported basis (4% on a constant currency basis) compared to the prior year period.

Oncology Products - Bard’s oncology business includes specialty vascular access products and enteral feeding devices. Specialty vascular access products include peripherally inserted central catheters (“PICCs”) used for intermediate to long-term central venous access, specialty access ports and accessories (“Ports”) used most commonly for chemotherapy, dialysis access catheters and vascular access ultrasound devices, which help facilitate the placement of PICCs. Consolidated net sales of oncology products for the quarter ended June 30, 2015 increased 5% on a reported basis (8% on a constant currency basis) compared to the prior year quarter. Consolidated net sales of oncology products for the six months ended June 30, 2015 increased 4% on a reported basis (6% on a constant currency basis) compared to the prior year period. These increases were primarily due to growth in sales of PICCs and were partially offset by declines in sales of Ports. United States net sales of oncology products for the quarter ended June 30, 2015 increased 5% compared to the prior year quarter. International net sales of oncology products for the quarter ended June 30, 2015 increased 5% on a reported basis (17% on a constant currency basis) compared to the prior year quarter. United States net sales of oncology products for the six months ended June 30, 2015 increased 3% compared to the prior year period. International net sales of oncology products for the six months ended June 30, 2015 increased 5% on a reported basis (16% on a constant currency basis) compared to the prior year period.

Consolidated net sales of PICCs for the quarter ended June 30, 2015 increased 9% on a reported basis (11% on a constant currency basis) compared to the prior year quarter. Consolidated net sales of PICCs for the six months ended June 30, 2015 increased 8% on a reported basis (10% on a constant currency basis) compared to the prior year period.

Consolidated net sales of Ports for the quarter ended June 30, 2015 decreased 3% on a reported basis (increased 1% on a constant currency basis) compared to the prior year quarter. Consolidated net sales of Ports for the six months ended June 30, 2015 decreased 4% on a reported basis (1% on a constant currency basis) compared to the prior year period.

Consolidated net sales of dialysis access catheters for the quarter ended June 30, 2015 increased 3% on a reported basis (7% on a constant currency basis) compared to the prior year quarter. Consolidated net sales of dialysis access catheters for the six months ended June 30, 2015 increased 4% on a reported basis (7% on a constant currency basis) compared to the prior year period. Consolidated net sales of vascular access ultrasound devices for the quarter ended June 30, 2015 increased 17% on a reported basis (20% on a constant currency basis) compared to the prior year quarter. Consolidated net sales of vascular access ultrasound devices for the six months ended June 30, 2015 increased 13% on a reported basis (16% on a constant currency basis) compared to the prior year period.

 

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Surgical Specialty Products - Surgical specialty products include soft tissue repair products, performance irrigation devices and biosurgery products, including hemostats and sealants. Consolidated net sales of surgical specialty products for the quarter ended June 30, 2015 increased 3% on a reported basis (6% on a constant currency basis) compared to the prior year quarter. Consolidated net sales of surgical specialty products for the six months ended June 30, 2015 increased 2% on a reported basis (5% on a constant currency basis) compared to the prior year period. These increases were primarily due to growth in sales of biosurgery products and synthetic hernia repair products and were partially offset by declines in sales of performance irrigation products, a trend that may continue. United States net sales of surgical specialty products for the quarter ended June 30, 2015 increased 6% compared to the prior year quarter. International net sales of surgical specialty products for the quarter ended June 30, 2015 decreased 3% on a reported basis (increased 9% on a constant currency basis) compared to the prior year quarter. United States net sales of surgical specialty products for the six months ended June 30, 2015 increased 5% compared to the prior year period. International net sales of surgical specialty products for the six months ended June 30, 2015 decreased 7% on a reported basis (increased 3% on a constant currency basis) compared to the prior year period. International net sales for both the quarter and six months ended June 30, 2015 reflected declines in sales of synthetic hernia repair products.

The soft tissue repair product line includes synthetic and natural tissue hernia repair implants, natural tissue breast reconstruction implants and hernia fixation products. Consolidated net sales of soft tissue repair products for the quarter ended June 30, 2015 increased 4% on a reported basis (8% on a constant currency basis) compared to the prior year quarter. Consolidated net sales of soft tissue repair products for the six months ended June 30, 2015 increased 3% on a reported basis (7% on a constant currency basis) compared to the prior year period. Net sales in this product line were favorably impacted by growth in sales of synthetic hernia repair products and were partially offset by declines in sales of hernia fixation products, a trend that may continue.

Consolidated net sales of biosurgery products for the quarter ended June 30, 2015 increased 19% on both a reported basis and constant currency basis compared to the prior year quarter. Consolidated net sales of biosurgery products for the six months ended June 30, 2015 increased 15% on both a reported basis and constant currency basis compared to the prior year period. Net sales in the product line were favorably impacted by growth in sales of hemostats and surgical sealant products.

Other Products - The other product group includes irrigation, wound drainage and certain original equipment manufacturers’ products.

Costs and Expenses

A summary of costs and expenses as a percentage of net sales is as follows:

 

     Quarter Ended
June 30,
    Six Months Ended
June 30,
 
     2015     2014     2015(A)     2014  

Cost of goods sold

     38.8     38.8     38.4     38.7

Marketing, selling and administrative expense

     29.1     29.6     28.9     29.6

Research and development expense

     7.4     10.3     7.4     9.2

Interest expense

     1.3     1.4     1.3     1.4

Other (income) expense, net

     16.5     31.1     9.4     15.5
  

 

 

   

 

 

   

 

 

   

 

 

 

Total costs and expenses

  93.1   111.2   85.5   94.4
  

 

 

   

 

 

   

 

 

   

 

 

 

 

(A)  Amounts do not add due to rounding.

Cost of goods sold - Cost of goods sold consists principally of the manufacturing and distribution costs of the company’s products. The category also includes royalties paid by the company, amortization of intangible assets and the impact of certain hedging activities. Cost of goods sold as a percentage of net sales for the quarter ended June 30, 2015 was flat compared to the prior year quarter. Cost of goods sold as a percentage of net sales for the six months ended June 30, 2015 decreased 30 basis points compared to the prior year period primarily due to a reversal of a liability with respect to a certain revenue-based milestone. Incremental amortization of intangible assets primarily related to the Lutonix drug-coated PTA balloon increased cost of goods sold as a percentage of net sales by approximately 40 basis points over the prior year quarter and six month period. These increases were partially offset by cost improvements.

Marketing, selling and administrative expense - Marketing, selling and administrative expense consists principally of the costs associated with the company’s sales and administrative organizations. These costs as a percentage of net sales for the quarter and six months ended June 30, 2015 decreased 50 basis points and 70 basis points, respectively, compared to the prior year periods.

 

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Research and development expense - Research and development expense consists principally of costs related to internal research and development activities, milestone payments for third-party research and development activities, and acquired in-process R&D (“IPR&D”) costs arising from the company’s business development activities. IPR&D payments may impact the comparability of the company’s results of operations between periods. Research and development expense for the quarter ended June 30, 2015 was $64.0 million, a decrease of approximately 25% compared to the prior year quarter. Research and development expense for the six months ended June 30, 2015 was $124.6 million, a decrease of approximately 17% compared to the prior year period. The decrease for the quarter and six months ended June 30, 2014 was primarily due to a charge of $20.7 million primarily related to the change in the fair value of the liability for contingent consideration related to the Lutonix, Inc. acquisition.

Interest expense - Interest expense was $11.2 million and $11.3 million for the quarters ended June 30, 2015 and 2014, respectively. Interest expense was $22.5 and $22.4 million for the six months ended June 30, 2015 and 2014, respectively.

Other (income) expense, net - The components of other (income) expense, net, are as follows:

 

     Quarter Ended
June 30,
     Six Months Ended
June 30,
 
     2015      2014      2015      2014  
(dollars in millions)                            

Interest income

   $ (0.1    $ (1.1    $ (0.4    $ (1.4

Foreign exchange losses (gains)

     0.8         (2.0      1.1         (1.2

Litigation charges, net

     343.7         262.7         354.0         262.7   

Gore Proceeds

     (210.5      —           (210.5      —     

Restructuring and productivity initiative costs

     8.5         —           12.4         —     

Gain on sale of investment

     —           —           —           (7.1

Other, net

     (0.7      (2.3      1.4         (1.7
  

 

 

    

 

 

    

 

 

    

 

 

 

Total other (income) expense, net

$ 141.7    $ 257.3    $ 158.0    $ 251.3   
  

 

 

    

 

 

    

 

 

    

 

 

 

Litigation charges, net – For the quarter and six months ended June 30, 2015, the amounts reflect the estimated costs for product liability matters, net of recoveries, and litigation-related defense costs of $6.8 million and $15.1 million, respectively, in connection with the District Court’s pre-trial orders to prepare 200 and then an additional 300 individual cases for trial (the “WHP Pre-Trial Orders”). For the six months ended June 30, 2015, the amount reflects certain other litigation-related charges. For the quarter and six months ended June 30, 2014, the amounts reflect the estimated costs for product liability matters, net of recoveries, and litigation-related defense costs of $4.2 million in connection with the District Court’s pre-trial order to prepare the 200 individual cases for trial. See Note 7 of the notes to condensed consolidated financial statements.

Gore Proceeds – See Note 7 of the notes to condensed consolidated financial statements.

Restructuring and productivity initiative costs – For the quarter and six months ended June 30, 2015, the amounts primarily reflect costs incurred in connection with productivity initiatives to streamline certain general and administrative functions to better align resources to the company’s business strategies. Key activities under these initiatives may include systems enhancements, the implementation of shared services centers designed to standardize and centralize processes or the outsourcing of certain services. Productivity initiative costs include consulting costs, primarily related to program creation and management, employee separation costs under the company’s existing severance program, and other related costs. For the quarter and six months ended June 30, 2015, employee separation costs of $1.6 million were recognized related to these initiatives.

Gain on sale of investment – For the six months ended June 30, 2014, the amount reflects the sale of an equity investment in an e-commerce technology company.

Income Tax Provision

The effective tax rate for the quarter and six months ended June 30, 2015 reflected the discrete tax effects of litigation charges, primarily related to product liability claims, which were substantially incurred in a low tax jurisdiction, and the gain related to the Gore Proceeds, which was incurred in a high tax jurisdiction. The effective tax rate for the quarter and six months ended June 30, 2014 reflected the discrete tax effect of litigation charges, primarily related to product liability claims, which were substantially incurred in a low tax jurisdiction. See Note 7 of the notes to condensed consolidated financial statements. The effective tax rate for the six months ended June 30, 2014 also reflected a tax benefit of $10.9 million as a result of the completion of U.S. Internal Revenue Service examinations for the tax years 2008 through 2010.

 

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Net (Loss) Income and (Loss) Earnings Per Share Available to Common Shareholders

The company reported net loss and diluted loss per share available to common shareholders for the quarter ended June 30, 2015 of $54.7 million and $0.74, respectively. Net loss and diluted loss per share available to common shareholders for the prior year quarter were $119.4 million and $1.59, respectively. The current year quarter reflects litigation charges, net, of $331.2 million, or $4.32 per diluted share, Gore Proceeds of $131.7 million, or $1.72 per diluted share, amortization of intangible assets of $19.4 million, or $0.25 per diluted share, restructuring and productivity initiative costs of $5.5 million, or $0.07 per diluted share, and net charges from acquisition-related items (primarily consisting of transaction costs and integration costs) of $4.0 million, or $0.05 per diluted share. The prior year quarter reflects litigation charges, net, of $240.3 million, or $3.08 per diluted share, amortization of intangible assets of $17.7 million, or $0.23 per diluted share, and charges from acquisition-related items (primarily consisting of purchase accounting adjustments, transaction costs and integration costs) of $22.1 million, or $0.28 per diluted share. See Note 3 of the notes to condensed consolidated financial statements.

The company reported net income and diluted earnings per share available to common shareholders for the six months ended June 30, 2015 of $85.1 million and $1.11, respectively. Net income and diluted earnings per share available to common shareholders for the six months ended June 30, 2014 were $29.0 million and $0.37, respectively. The current year six month period reflects litigation charges, net, of $340.6 million, or $4.43 per diluted share, Gore Proceeds of $131.7 million, or $1.71 per diluted share, amortization of intangible assets of $38.6 million, or $0.50 million per diluted share, restructuring and productivity initiative costs of $8.1 million, or $0.11 per diluted share, and a net benefit from acquisition-related items (primarily consisting of purchase accounting adjustments, transaction costs and integration costs) of $5.4 million, or $0.07 per diluted share. The prior year six month period reflects litigation charges, net, of $240.3 million, or $3.05 per diluted share, amortization of intangible assets of $35.4 million, or $0.45 per diluted share, net charges from acquisition-related items (primarily consisting of purchase accounting adjustments, integration costs and transaction costs) of $24.4 million, or $0.31 per diluted share, and a gain on sale of an equity investment of $4.9 million, or $0.06 per diluted share. The prior year six month period also reflects a $10.9 million, or $0.14 per diluted share, benefit to the income tax provision as a result of the completion of IRS examinations for the tax years 2008 through 2010.

Liquidity and Capital Resources

The company assesses its liquidity in terms of its ability to generate cash to fund its operating, investing and financing activities. Significant factors affecting the management of liquidity are cash flows generated from operating activities, capital expenditures, acquisitions of businesses and technologies, cash dividends and common stock repurchases. Cash provided from operations continues to be a primary source of funds. The company believes that it could borrow adequate funds at competitive terms should it be necessary. The company also believes that its overall financial strength gives it sufficient financial flexibility. A summary of certain liquidity measures for the company as of June 30, is as follows:

 

     2015      2014  
(dollars in millions)              

Working capital

   $ 1,063.1       $ 1,243.8   
  

 

 

    

 

 

 

Current ratio

  1.96/1      2.59/1   
  

 

 

    

 

 

 

Cash and cash equivalents held by the company’s foreign subsidiaries were $1,066.3 million and $950.9 million at June 30, 2015 and December 31, 2014, respectively. It is the company’s intention to permanently reinvest the majority of these funds outside the United States to finance foreign operations, and the company’s plans do not demonstrate a need to repatriate these funds. If these funds are needed for U.S. operations for currently unforeseen circumstances or can no longer be permanently reinvested outside the United States, the company would be required to accrue and pay U.S. taxes on the earnings associated with these funds. In the United States, ongoing operating cash flows and available borrowings under the company’s committed syndicated bank credit facility provide it with sufficient liquidity.

For the six months ended June 30, 2015 and 2014, net cash provided by operating activities was $507.4 million and $284.0 million, respectively. The increase in net cash provided by operating activities is primarily due to the receipt of the Gore Proceeds and lower tax payments in the current year period and was partially offset by higher payments to claimants for certain product liability matters in the current year period, and improvements in accounts receivable collections in the prior year period.

For the six months ended June 30, 2015 and 2014, net cash used by investing activities was $26.3 million and $42.2 million, respectively. Capital expenditures were approximately $57.6 million and $55.6 million for the six months ended June 30, 2015 and 2014, respectively. The current year reflects a decrease of $31.7 million in restricted cash primarily related to payments from qualified settlement funds for certain product liability matters. In addition, the company received proceeds from the sale of an investment of $7.1 million during the six months ended June 30, 2014.

 

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For the six months ended June 30, 2015 and 2014, net cash used for financing activities was $321.6 million and $314.4 million, respectively. Total debt was $1.4 billion (including current maturities of $252.5 million) and $1.5 billion at June 30, 2015 and December 31, 2014, respectively. Total debt to total capitalization was 45.8% and 45.1% at June 30, 2015 and December 31, 2014, respectively. Net cash used in financing activities reflects $236.6 million used to repurchase 1,378,136 shares of common stock in the six months ended June 30, 2015 compared to $526.1 million to repurchase 3,712,560 shares of common stock in the prior year period. The company paid cash dividends of $0.44 per share and $0.42 per share for the six months ended June 30, 2015 and 2014, respectively.

The company maintains a $750 million five-year committed syndicated bank credit facility that expires in November 2019. The credit facility supports the company’s commercial paper program and can be used for general corporate purposes. The facility includes pricing based on the company’s long-term credit ratings and includes a financial covenant that limits the amount of total debt to total capitalization. At June 30, 2015, the company was in compliance with this covenant. There were no commercial paper borrowings outstanding at June 30, 2015. Commercial paper borrowings outstanding at December 31, 2014 were $78.0 million.

Contingencies

In the ordinary course of business, the company is subject to various legal proceedings and claims, including product liability matters, environmental matters, employment disputes, contractual disputes on agreements and other commercial disputes. In addition, the company operates in an industry susceptible to significant patent legal claims. At any given time in the ordinary course of business, the company is involved as either a plaintiff or defendant in a number of patent infringement actions. See Note 7 of the notes to condensed consolidated financial statements.

Certain Regulatory Matters

In October 2014 and November 2014, the United States Food and Drug Administration (“FDA”) conducted directed inspections at two of the company’s facilities after which the FDA issued Form-483’s to the company in connection with these inspections. The company responded to the FDA, is in the process of addressing the observations in the Form-483’s and intends to fully implement corrective and preventive actions to address the FDA’s concerns. On July 14, 2015, the company received a Warning Letter from the Los Angeles District office of the FDA. The Warning Letter specifically cites quality systems and medical device reporting observations relating to non-conformances previously identified in the Form-483 notices for Glens Falls, New York and Tempe, Arizona and appropriate market clearance or approval of two models of our Recovery Cone Removal Systems used to retrieve certain implanted filters. The Warning Letter states that, until the company resolves the outstanding issues covered by the Warning Letter, no premarket submissions for Class III devices to which the non-conformances are reasonably related will be cleared or approved. The company presently has two such submissions before the FDA, which the company does not believe are material to its business. The company intends to fully implement corrective actions to address the concerns identified in the Warning Letter. However, the company cannot give any assurances that the FDA will be satisfied with its response to the Warning Letter or to the expected date of resolution of matters included in the Warning Letter. Although the company cannot give any assurances that the resolution of these matters will not have a material adverse effect on the company’s business, results of operations, financial conditions and/or liquidity, the company does not at this time believe this will have a material impact on its financial statements.

Management’s Use of Non-GAAP Measures

Net sales “on a constant currency basis” is a non-GAAP measure. The company analyzes net sales on a constant currency basis to better measure the comparability of results between periods. Because changes in foreign currency exchange rates have a non-operating impact on net sales, the company believes that evaluating growth in net sales on a constant currency basis provides an additional and meaningful assessment of net sales to both management and the company’s investors. Constant currency growth rates are calculated by translating the prior year’s local currency sales by the current period’s exchange rate. Constant currency growth rates are not indicative of changes in corresponding cash flows. The limitation of these non-GAAP measures is that they do not reflect results on a standardized reporting basis. Non-GAAP measures are intended to supplement the applicable GAAP disclosures and should not be viewed as replacements of GAAP results.

Critical Accounting Policies

The preparation of financial statements requires the company’s management to make estimates and assumptions that affect the reported amount of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial

 

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statements and the reported amounts of revenues and expenses during the reporting period. Critical accounting policies are those that require application of management’s most difficult, subjective or complex judgments, often as a result of the need to make estimates about the effect of matters that are inherently uncertain and may change in subsequent periods. Such policies are summarized in the Management’s Discussion and Analysis of Financial Condition and Results of Operations section in Bard’s 2014 Annual Report on Form 10-K. There have been no significant changes to the company’s critical accounting policies since December 31, 2014.

Risks and Uncertainties; Cautionary Statement Regarding Forward-Looking Information

Certain statements contained herein or in other company documents and certain statements that may be made by management of the company orally may contain forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995. You can identify these statements by the fact that they do not relate strictly to historical or current facts. They use words such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “forecast,” “plan,” “believe” and other words and terms of similar meaning in connection with any discussion of future operating or financial performance. In particular, these include statements relating to product approvals, future performance of current and anticipated products, sales efforts, expenses, the outcome of contingencies, such as legal proceedings, and financial results. The company’s forward-looking statements speak only as of the date of this report or as of the date they are made, and the company undertakes no obligation to update its forward-looking statements.

In addition, there are substantial risks inherent in the medical device business. The company’s business involves the design, development, manufacture, packaging, distribution and sale of life-sustaining medical devices. These devices are often used on, or permanently or temporarily implanted in, patients in clinically demanding circumstances, such as operating rooms, emergency units, intensive care and critical care settings, among others. These circumstances, among other factors, can cause the products to become associated with adverse clinical events, including patient mortality and injury, and could lead to product liability claims (including lawsuits seeking class action status or seeking to establish multi-district litigation proceedings) and other litigation, product withdrawals, warning letters, recalls, field corrections or regulatory enforcement actions relating to one or more of the company’s products, any of which could have a material adverse effect on our business, results of operations, financial condition and/or liquidity. For further discussion of risks applicable to our business, see “Risk Factors” in Bard’s 2014 Annual Report on Form 10-K.

Because actual results are affected by these and other risks and uncertainties, the company cautions investors that actual results may differ materially from those expressed or implied. It is not possible to predict or identify all risks and uncertainties, but the most significant factors, in addition to those addressed above and those described under Item 1A. “Risk Factors” in Bard’s 2014 Annual Report on Form 10-K, that could adversely affect our business or cause the actual results to differ materially from those expressed or implied include, but are not limited to:

Effective management of and reaction to risks involved in our business, including:

 

    the ability to achieve manufacturing or administrative efficiencies, including gross margin benefits from our manufacturing processes and supply chain programs or in connection with the integration of acquired businesses;

 

    the effects of negative publicity concerning our products, which could result in product withdrawals or decreased product demand and which could reduce market or governmental acceptance of our products;

 

    the ability to identify appropriate companies, businesses and technologies as potential acquisition candidates, to consummate and successfully integrate such transactions or to obtain agreements for such transactions on favorable terms;

 

    the reduction in the number of procedures using our devices caused by customers’ cost-containment pressures or preferences for alternate therapies;

 

    the ability to implement, and realize the benefits of, our prior and planned investments in our business, including research and development expenditures focused on new market categories, and our plan to grow in emerging and/or faster-growing markets outside the United States and acquire growth platforms designed to change the mix of our portfolio towards faster, sustainable long-term growth;

 

    the uncertainty of whether research and development expenditures and sales force expansion will result in increased sales;

 

    the ability to reduce exposure and uncertainty related to tax audits, appeals and litigation;

 

    the risk that the company may not successfully implement its expansion of its Enterprise Resource Planning (“ERP”) information system and other productivity initiatives;

 

    internal factors, such as retention of key employees, including sales force employees;

 

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    the ability to achieve earnings forecasts, which are generated based, among other things, on projected volumes and sales of many product types, some of which are more profitable than others, and projected royalty revenue from Gore;

 

    changes in factors and assumptions or actual results that differ from our assumptions on stock valuation and employee stock option exercise patterns, which could cause compensation expense recorded in future periods to differ significantly from the compensation expense recorded in the current period;

 

    changes in factors and assumptions could cause pension cost recorded in future periods to differ from the pension cost recorded in the current period;

 

    the effect of market fluctuations on the value of assets in the company’s pension plans and the possibility that the company may need to make additional contributions to the plans as a result of any decline in the fair value of such assets;

 

    damage to a facility where our products are manufactured or from which they are distributed, which could render the company unable to manufacture or distribute one or more products and may require the company to reduce the output of products at the damaged facility thereby making it difficult to meet product shipping targets;

 

    the potential impairment of goodwill and intangible assets of the company resulting from insufficient cash flow generated from such assets specifically, or our business more broadly, so as to not allow the company to justify the carrying value of the assets;

 

    the ability to obtain appropriate levels of insurance on reasonable terms, or at all;

 

    the ability to recover for claims made to our insurance companies or under indemnification obligations to the company and that any amounts recovered under these arrangements may not be adequate to cover the company’s damages and/or costs; and

 

    the ability to realize the anticipated benefits of our restructuring activities to improve the company’s overall cost structure and improve efficiency.

Competitive factors, including:

 

    the trend of consolidation in the medical device industry as well as among our customers, resulting in potentially greater pricing pressures, competition and more significant and complex contracts than in the past, both in the United States and abroad;

 

    development of new products or technologies by competitors having superior performance compared to our current products or products under development which could negatively impact sales of our products or render one or more of our products obsolete;

 

    technological advances, patents and registrations obtained by competitors that would have the effect of excluding the company from new market segments or preventing the company from selling a product or including key features in the company’s products;

 

    attempts by competitors to gain market share through aggressive marketing programs; and

 

    reprocessing by third-party reprocessors of our products designed and labeled for single use.

Difficulties and delays inherent in the development, manufacturing, marketing and sale of medical products, including:

 

    the ability to complete planned and/or ongoing clinical trials successfully, to develop and obtain regulatory approval for products on a timely basis and to launch products on a timely basis within cost estimates;

 

    lengthy and costly regulatory approval processes, which may result in lost market opportunities and/or delayed product launches;

 

    delays or denials of, or grants of low or reduced levels of reimbursement for, procedures using newly developed products;

 

    the suspension or revocation of authority to manufacture, market or distribute existing products;

 

    the imposition of additional or different regulatory requirements, such as those affecting manufacturing and labeling;

 

    performance, efficacy, quality or safety concerns for existing products, whether scientifically justified or not, that may lead to product discontinuations, product withdrawals, recalls, field corrections, regulatory enforcement actions, litigation or declining sales, including adverse events and/or concerns relating to the company’s vena cava filters, pelvic floor repair products and hernia repair products;

 

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    FDA inspections resulting in Form-483 notices and/or warning letters identifying deficiencies in the company’s manufacturing practices and/or quality systems; warning letters identifying violations of FDA regulations that could result in product holds, recalls, restrictions on future clearances by the FDA and/or civil penalties; uncertainty regarding the expected date of resolution of any of these matters;

 

    the failure to obtain, limitations on the use of, or the loss of, patent and other intellectual property rights, and the failure of efforts to protect our intellectual property rights against infringement and legal challenges that can increase our costs;

 

    difficulties obtaining necessary components or raw materials used in the company’s products and/or price increases from the company’s suppliers of critical components or raw materials, including oil-based resins, or other interruptions of the supply chain; and

 

    customers that may limit the number of manufacturers or vendors from which they will purchase products, which can result in the company’s inability to sell products to or contract with large hospital systems, integrated delivery networks or group purchasing organizations.

Governmental action, including:

 

    the impact of continued healthcare cost containment;

 

    new laws and judicial decisions related to healthcare availability, healthcare reform, payment for healthcare products and services or the marketing and distribution of products, including legislative or administrative reforms to the United States Medicare and Medicaid systems or other United States or international reimbursement systems in a manner that would significantly reduce or eliminate reimbursements for procedures that use the company’s products;

 

    changes in the FDA and/or foreign regulatory approval processes that may delay or prevent the approval of new products and result in lost market opportunity;

 

    the impact of compliance and enforcement activities affecting the healthcare industry in general or the company in particular (including sales and marketing practices);

 

    changes in tax laws affecting our business, such as proposed comprehensive tax reform in the United States and proposed legislation in multiple jurisdictions resulting from the adoption of Organisation for Economic Co-operation and Development (OECD) policies;

 

    changes in environmental laws or standards affecting our business including, among others, compliance with new labeling standards related to ozone-depleting substances;

 

    changes in laws that could require facility upgrades or process changes and could affect production rates and output; and

 

    compliance costs and potential penalties and remediation obligations in connection with environmental laws, including regulations regarding air emissions, waste water discharges and solid waste.

Legal disputes, including:

 

    disputes over legal proceedings, the outcome of the Gore matters and the timing of final resolution of the Gore matters, including the patent infringement suit against Gore;

 

    product liability claims, which may involve lawsuits seeking class action status or seeking to establish multi-district litigation proceedings, including the Hernia Product Claims, the Women’s Health Product Claims and the Filter Product Claims;

 

    claims asserting securities law violations;

 

    claims asserting, and/or subpoenas seeking information regarding, violations of law in connection with federal and/or state healthcare programs such as Medicare or Medicaid;

 

    derivative shareholder actions;

 

    claims and subpoenas asserting antitrust violations;

 

    environmental claims, including risks relating to accidental contamination or injury from the use of hazardous materials in the company’s manufacturing, sterilization and research activities and the potential for the company to be held liable for any resulting damages; and

 

    commercial disputes, including disputes over distribution agreements, license agreements, manufacturing/supply agreements, development/research agreements (including indemnification provisions), acquisition or sale agreements, and insurance policies.

 

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General economic conditions, including:

 

    international and domestic business conditions;

 

    political or economic instability in foreign countries;

 

    interest rates;

 

    foreign currency exchange rates;

 

    changes in the rate of inflation; and

 

    instability of global financial markets and economies including Greece, Italy, Spain, Portugal and certain other countries or places where we operate or do business.

Other factors beyond our control, including catastrophes, both natural and man-made, earthquakes, floods, fires, explosions, strikes, work stoppages or slowdowns, acts of terrorism or war.

Item 3. Quantitative and Qualitative Disclosures About Market Risk

The quantitative and qualitative disclosures about market risk are discussed in “Part II, Item 7A. Quantitative and Qualitative Disclosures About Market Risk” in Bard’s 2014 Annual Report on Form 10-K. There have been no material changes in the information reported since the year ended December 31, 2014.

Item 4. Controls and Procedures

The company maintains disclosure controls and procedures that are designed to ensure that information required to be disclosed in the company’s reports under the Securities Exchange Act of 1934 (the “Exchange Act”) is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to the company’s management, including its Chief Executive Officer and Chief Financial Officer, as appropriate, to allow for timely decisions regarding required disclosures. Any controls and procedures, no matter how well defined and operated, can provide only reasonable assurance of achieving the desired control objectives.

The company’s management, with the participation of the company’s Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of the design and operation of the company’s disclosure controls and procedures as of June 30, 2015. Based upon that evaluation, the company’s Chief Executive Officer and Chief Financial Officer have concluded that, as of June 30, 2015, the design and operation of the company’s disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) were effective to accomplish their objectives at the reasonable assurance level. There have been no changes in internal control over financial reporting for the quarter ended June 30, 2015 that have materially affected, or are likely to materially affect, the company’s internal control over financial reporting.

PART II – OTHER INFORMATION

Item 1. Legal Proceedings

In the ordinary course of business, the company is subject to various legal proceedings, investigations and claims, including, for example, environmental matters, employment disputes, disputes on agreements and other commercial disputes. In addition, the company operates in an industry susceptible to significant product liability and patent legal claims. At any given time, in the ordinary course of business, the company is involved as either a plaintiff or defendant in a number of patent infringement actions. If a third party’s patent infringement claim were to be determined against the company, the company might be required to make significant royalty or other payments or might be subject to an injunction or other limitation on its ability to manufacture or distribute one or more products. If a patent owned by or licensed to the company is found to be invalid or unenforceable, the company might be required to reduce the value of certain intangible assets on the company’s balance sheet and to record a corresponding charge, which could be significant in amount. Many of the company’s legal proceedings and claims could have a material adverse effect on its business, results of operations, financial condition and/or liquidity.

Product Liability Matters

Hernia Product Claims

As of July 1, 2015, approximately 45 federal and 40 state lawsuits involving individual claims by approximately 85 plaintiffs, as well as one putative class action in the United States, are currently pending against the company with respect to its Composix® Kugel® and certain other hernia repair implant products (collectively, the “Hernia Product Claims”). The company voluntarily recalled certain sizes and lots of the Composix® Kugel® products beginning in December 2005. As of July 1, 2015, all but one of the putative class actions pending against the company were dismissed. The remaining putative class action, which has not been certified, seeks: (i) medical monitoring; (ii) compensatory damages; (iii) punitive damages; (iv) a judicial finding of defect and causation; and/or (v) attorneys’ fees. In April 2014, a settlement was reached with respect

 

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to the three putative Canadian class actions within amounts previously recorded by the company. Approximately 25 of the state lawsuits, involving individual claims by approximately 25 plaintiffs, are pending in the Superior Court of the State of Rhode Island, with the remainder in various other jurisdictions. The Hernia Product Claims also generally seek damages for personal injury resulting from use of the products.

In June 2007, the Composix® Kugel® lawsuits and, subsequently, other hernia repair product lawsuits, pending in federal courts nationwide were transferred into one Multidistrict Litigation (“MDL”) for coordinated pre-trial proceedings in the United States District Court for the District of Rhode Island.

In June 2011, the company announced that it had reached agreements in principle with various plaintiffs’ law firms to settle the majority of its existing Hernia Product Claims. Each agreement was subject to certain conditions, including requirements for participation in the proposed settlements by a certain minimum number of plaintiffs. In addition, the company continues to engage in discussions with other plaintiffs’ law firms regarding potential resolution of unsettled Hernia Product Claims, and intends to vigorously defend Hernia Product Claims that do not settle, including through litigation. There are two trials currently scheduled in the second half of 2015. The company cannot give any assurances that the resolution of the Hernia Product Claims that have not settled, including asserted and unasserted claims and the putative class action lawsuit, will not have a material adverse effect on the company’s business, results of operations, financial condition and/or liquidity.

Women’s Health Product Claims

As of July 1, 2015, product liability lawsuits involving individual claims by approximately 15,260 plaintiffs have been filed against the company in various federal and state jurisdictions alleging personal injuries associated with the use of certain of the company’s surgical continence products for women. In addition, five putative class actions in the United States and five putative class actions in Canada have been filed against the company. In addition, a limited number of claims have been filed or asserted in various non-U.S. jurisdictions (all lawsuits, collectively, the “Women’s Health Product Claims”). The Women’s Health Product Claims generally seek damages for personal injury resulting from use of the products. The putative class actions, none of which has been certified, seek: (i) medical monitoring; (ii) compensatory damages; (iii) punitive damages; (iv) a judicial finding of defect and causation; and/or (v) attorneys’ fees. In April 2015, the Ontario Superior Court of Justice dismissed the plaintiffs’ motion for class certification in one Canadian putative class action. The plaintiffs may appeal this decision or may file an alternatives motion with the Ontario Superior Court to redefine the class. With respect to approximately half of the filed and asserted Women’s Health Product Claims, the company believes that two subsidiaries of Medtronic plc (as successor in interest to Covidien plc) (“Medtronic”), each a supplier of the company, have an obligation to defend and indemnify the company with respect to any product defect liability. As described below, in July 2015 the company reached an agreement with Medtronic regarding certain aspects of Medtronic’s indemnification obligation.

In October 2010, the Women’s Health Product Claims involving solely Avaulta® products pending in federal courts nationwide were transferred into an MDL in the United States District Court for the Southern District of West Virginia (the “District Court”), the scope of which was later expanded to include lawsuits involving all women’s surgical continence products that are manufactured or distributed by the company. The first trial in a state court was completed in California in July 2012 and resulted in a judgment against the company of approximately $3.6 million. On appeal the decision was affirmed by the appellate court in November 2014. The company filed a petition for review to the California Supreme Court on December 24, 2014, which was denied on February 18, 2015. The judgment in this matter, including interest and costs, was paid on March 20, 2015 within the amounts previously recorded by the company. The first trial in the MDL commenced in July 2013 and resulted in a judgment against the company of approximately $2 million. The company has appealed this decision. During the third quarter of 2013, the company settled one MDL case and one New Jersey state case. In addition, during the third quarter of 2013, one MDL case was voluntarily dismissed with prejudice. On January 16, 2014 and July 31, 2014, the District Court ordered that the company prepare 200 and then an additional 300 individual cases, respectively, for trial (the “WHP Pre-Trial Orders”) (the timing for which is currently unknown). The WHP Pre-Trial Orders resulted in significant additional litigation-related defense costs beginning in the second quarter of 2014 and continuing through the second quarter of 2015. In June 2015, the District Court issued an order staying the requirement to prepare a significant portion of the cases covered by the WHP Pre-Trial Orders. The WHP Pre-Trial Orders may result in material additional cost in the second half of 2015 in defending Women’s Health Product Claims. The District Court may also order that the company prepare additional cases for trial, which could result in material additional cost in future periods. During the second quarter of 2014, the company reached an agreement with two plaintiffs’ law firms to settle their inventory of cases, representing more than 500 of the filed or asserted Women’s Health Product Claims, which the company believes are not the subject of Medtronic’s indemnification obligation. The company also settled one MDL case that was originally scheduled for trial in May 2014. In the third quarter of 2014, the company reached an agreement with a plaintiffs’ law firm to settle approximately 25 of the filed or asserted Women’s Health Product Claims, which the company believes are not the subject of Medtronic’s indemnification obligation. The settlements reached in 2014 for Women’s Health Product Claims were within the amounts

 

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previously recorded by the company. In February 2015, the District Court appointed a Special Master to assist with settlement resolution. A trial was scheduled to begin in the MDL in February 2015, which the parties settled before trial. In June 2015, the company reached an agreement in principle with various plaintiffs’ law firms to settle their inventory of cases, representing more than 1,300 of the filed or asserted Women’s Health Product Claims. In July 2015, the company reached an agreement with various plaintiffs’ law firms to settle their inventory of cases, representing more than 1,500 of the filed or asserted Women’s Health Product Claims. Each agreement is subject to certain conditions, including requirements for participation in the proposed settlements by a certain minimum number of plaintiffs. In addition, the company continues to engage in discussions with other plaintiffs’ law firms regarding potential resolution of unsettled Women’s Health Product Claims, which may include additional inventory settlements. Notwithstanding these settlement efforts, the company anticipates that multiple additional trials, including one or more possible consolidated trials, may occur in 2015.

In December 2014, Medtronic filed a motion for leave to amend its answer in the underlying MDL for Women’s Health Product Claims to assert cross-claims against the company challenging the indemnification provisions of certain of their supply agreements with the company. In March 2015, the court granted Medtronic’s motion. On January 22, 2015, the company initiated litigation and/or arbitration seeking, among other things, declaratory relief under these supply agreements with Medtronic in three separate jurisdictions – New Jersey state court, the English High Court of Justice in London and Atlanta, Georgia. In July 2015, as part of the agreement noted above, Medtronic agreed to take responsibility for pursuing settlement of certain of the Women’s Health Product Claims that relate to products distributed by the company under supply agreements with Medtronic and the company agreed to pay Medtronic $121 million towards these potential settlements. The company also may, in its sole discretion, transfer responsibility for settlement of additional Women’s Health Product Claims to Medtronic on similar terms. The agreement does not resolve the dispute between the company and Medtronic with respect to Women’s Health Product Claims that do not settle, if any. As part of the agreement, Medtronic and the company agreed to dismiss without prejudice their pending litigation with respect to Medtronic’s obligation to defend and indemnify the company.

The company does not believe that any verdicts entered to date are representative of potential outcomes of all Women’s Health Product Claims. The case numbers set forth above do not include approximately 815 generic complaints involving women’s health products where the company cannot, based on the allegations in the complaints, determine whether any of those cases involve the company’s women’s health products. In addition, the case numbers set forth above do not include approximately 1,555 claims that have been threatened against the company but for which complaints have not yet been filed. While the company continues to engage in discussions with other plaintiffs’ law firms regarding potential resolution of unsettled Women’s Health Product Claims and intends to vigorously defend the Women’s Health Product Claims that do not settle, including through litigation, it cannot give any assurances that the resolution of these claims will not have a material adverse effect on the company’s business, results of operations, financial condition and/or liquidity.

Filter Product Claims

As of July 1, 2015, product liability lawsuits involving individual claims by approximately 50 plaintiffs are currently pending against the company in various federal and state jurisdictions alleging personal injuries associated with the use of the company’s vena cava filter products (all lawsuits, collectively, the “Filter Product Claims”). The first Filter Product Claim trial was completed in June 2012 and resulted in a judgment for the company. During the second quarter of 2013, the company finalized settlement agreements with respect to more than 30 Filter Product Claims and made payments with respect to such claims within the amounts previously recorded by the company. The case numbers set forth above do not include approximately 145 claims that have been threatened against the company but for which complaints have not yet been filed. The company expects additional trials of Filter Product Claims to take place over the next 12 months. While the company intends to vigorously defend Filter Product Claims that do not settle, including through litigation, it cannot give any assurances that the resolution of these claims will not have a material adverse effect on the company’s business, results of operations, financial condition and/or liquidity.

General

In most product liability litigations (like those described above), plaintiffs allege a wide variety of claims, ranging from allegations of serious injury caused by the products to efforts to obtain compensation notwithstanding the absence of any injury. In many of these cases, the company has not yet received and reviewed complete information regarding the plaintiffs and their medical conditions and, consequently, is unable to fully evaluate the claims. The company expects that it will receive and review additional information regarding any remaining unsettled product liability matters.

The company believes that some settlements and judgments, as well as some legal defense costs, relating to product liability matters are or may be covered in whole or in part under its product liability insurance policies with a limited number of insurance carriers, or, in some circumstances, indemnification obligations to the company from other parties. In certain circumstances, insurance carriers reserve their rights with respect to coverage, or contest or deny coverage, as has occurred with respect to certain claims. In addition, other parties may dispute their indemnification obligations to the company, as has occurred with respect to certain claims. When either of these occur, the company intends to vigorously contest disputes with

 

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respect to its insurance coverage or indemnification and to enforce its rights, and accordingly, will record expected recoveries with respect to amounts due under these policies or arrangements, when recovery is probable. Amounts recovered under the company’s product liability insurance policies or indemnification arrangements may be less than the stated coverage limits or less than otherwise expected and may not be adequate to cover damages and/or costs relating to claims. In addition, there is no guarantee that insurers or other parties will pay claims or that coverage or indemnity will be otherwise available.

The company’s insurance coverage with respect to the Hernia Product Claims has been exhausted. The company continues to evaluate its available insurance coverage as it relates to Women’s Health Product Claims and Filter Product Claims.

Other Legal Matters

Since early 2013, the company has received subpoenas or Civil Investigative Demands from a number of State Attorneys General seeking information related to the sales and marketing of certain of the company’s products that are the subject of the Hernia Product Claims and the Women’s Health Product Claims. The company is cooperating with these requests. Since it is not feasible to predict the outcome of these proceedings, the company cannot give any assurances that the resolution of these proceedings will not have a material adverse effect on the company’s business, results of operations, financial condition and/or liquidity.

In December 2007, a U.S. District Court jury in Arizona found that certain of Gore’s ePTFE vascular grafts and stent-grafts infringe the company’s patent number 6,436,135 (the “135 patent”). The jury upheld the validity of the company’s patent and awarded the company $185 million in past damages. The jury also found that Gore willfully infringed the patent. In a second phase of the trial, the District Court ruled that Gore failed to prove that the patent is unenforceable due to inequitable conduct. In March 2009, the District Court doubled the jury award to approximately $371 million for damages through June 2007. The District Court also awarded the company attorneys’ fees of $19 million and prejudgment interest of approximately $20 million. In addition, the District Court denied Gore’s remaining motions, including its motions for a new trial and to set aside the jury’s verdict. In July 2010, the District Court awarded the company approximately $109 million in additional damages for the period from July 2007 through March 2009. The District Court also assessed a royalty rate of between 12.5% and 20%, depending on the product, that is being used to calculate damages for Gore’s infringing sales from April 2009 through the expiration of the patent.

Gore appealed this matter to the Court of Appeals for the Federal Circuit (the “Court of Appeals”), which on February 10, 2012 affirmed the decision of the District Court. Gore filed a petition with the Court of Appeals for a rehearing of its appeal. On June 14, 2012, the Court of Appeals reaffirmed its February 10, 2012 decision, including the ongoing royalty rates as set by the District Court, with the exception of the issue of willfulness with respect to Gore’s infringement of the 135 patent, which was remanded to the District Court for further consideration. On October 12, 2012, Gore filed a petition for a writ of certiorari to the U.S. Supreme Court requesting a review of the portion of the decision that the Court of Appeals reaffirmed. The U.S. Supreme Court denied Gore’s petition on January 14, 2013.

On January 28, 2013, Gore filed with the District Court a Request for Judicial Notice that the U.S. Patent and Trademark Office (“USPTO”) granted Gore’s previously filed request for a re-examination of the 135 patent. On April 1, 2013, the USPTO issued a First Office Action initially rejecting all of the claims of the 135 patent that are the subject of the re-examination. On July 10, 2013, the USPTO issued a Notice of Intent to Issue an Ex Parte Reexamination Certificate upholding the patentability of all re-examined claims of the 135 patent. This action terminated the re-examination proceeding and upheld the claims involved in the re-examination.

On remand of the action from the Court of Appeals, the District Court heard oral argument on June 5, 2013 on three motions pending before it – Gore’s motion requesting a determination that Gore’s infringement was not willful, Gore’s motion for a new trial, and the company’s motion to execute on the judgment with respect to all amounts other than enhanced damages due to willfulness. On October 16, 2013, the District Court denied Gore’s motion for entry of a judgment holding that Gore’s infringement was not willful and Gore’s motion for a new trial. The District Court granted the company’s motion to execute on the judgment, holding that all aspects of the judgment relating to infringement were “final and non-appealable.” The District Court continued its stay on the execution of the judgment with respect to willfulness and the related enhanced damages.

On November 1, 2013, Gore paid to the company $894.3 million in cash the total amount of the compensatory damages for infringement, including pre- and post-judgment interest, and the royalties accrued through September 30, 2013. Gore expressly reserved its right to appeal from the District Court’s rulings and notified the company that, if successful on appeal, it would seek to recover the amounts paid to the company. On December 5, 2013, Gore filed an appeal in the Court of Appeals on all of the District Court’s rulings, including the order denying Gore’s motion for a new trial. On August 8, 2014, the Court of Appeals heard oral argument on Gore’s appeal of the District Court’s rulings. On January 13, 2015, the Court of Appeals affirmed the decision of the District Court regarding its determination that the company established standing and that the 135 patent was willfully infringed. On February 12, 2015, Gore filed a petition for rehearing en banc at the Court of

 

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Appeals on the issue of willfulness. On April 8, 2015, the Court of Appeals denied Gore’s petition for rehearing en banc on the issue of willfulness. The company filed a motion to execute on the judgment on the issue of willfulness, which was granted by the District Court on April 23, 2015. On May 1, 2015, Gore paid to the company $210.5 million in cash, representing the total amount of the enhanced damages awarded by the District Court due to Gore’s willfulness and an audit adjustment related to the payment of royalties through September 30, 2013. On July 7, 2015, Gore filed a petition for a writ of certiorari to the U.S. Supreme Court requesting a review of the decision that the 135 patent was infringed. The company believes Gore’s petition is without merit. Whether or not the Supreme Court will accept such petition, and the timing of such decision, is not known.

As of the third quarter of 2013, the company considered both the compensatory damages and the enhanced damages and the royalty awards to be contingent gains. In the fourth quarter of 2013, the company recorded a gain of $894.3 million ($557.4 million after tax) to other (income) expense, net, based on the District Court’s October 2013 rulings and the company’s receipt of the 2013 portion of the Gore Proceeds. In the second quarter of 2015, the company recorded a gain of $210.5 million ($131.7 million after tax) to other (income) expense, net, based on the District Court’s April 2015 ruling and the company’s receipt of the 2015 portion of the Gore Proceeds and an audit adjustment related to the payment of royalties through September 30, 2013. In April 2015, the company received $35.6 million of royalty payments from Gore representing Gore’s calculation of royalties for its infringing sales for the quarter ended March 31, 2015. This royalty payment and an audit adjustment of $1.3 million related to the payment of royalties from October 1, 2013 to March 31, 2015 were recorded to revenue in the second quarter of 2015. Royalty payments of $75.3 million were recorded to revenue for the six months ended June 30, 2015. The company has received cumulative proceeds from Gore of $1,331.9 million. The company has concluded that the chance of Gore establishing its right to recover any portion of the cumulative proceeds is remote.

The timing of final resolution of this litigation remains uncertain. The company cannot give any assurances that royalties for Gore’s future infringing sales will remain at or near historical levels.

In an unrelated matter, Gore filed suit in June 2011 in the U.S. District Court in Delaware alleging the company had infringed on several of Gore’s patents. Fact and expert discovery have been completed and in the fourth quarter of 2014, the parties both filed a number of motions, including motions for summary judgment. Oral arguments on the motions occurred on January 30, 2015. In June 2015, the Magistrate Judge of the Delaware District Court issued a preliminary ruling on three of these motions, granting the company’s motion for summary judgment on non-infringement of one of Gore’s patents and denying the company’s motions for summary judgment for patent invalidity due to the patents being indefinite and to exclude expert testimony of Gore’s technical expert. The rulings remain subject to the final approval of the Delaware District Court. The company intends to vigorously defend the allegations asserted by Gore. The company cannot give any assurances that an adverse resolution of this matter will not have a material adverse effect on the company’s business, results of operations, financial condition and/or liquidity.

The company is subject to numerous federal, state, local and foreign environmental protection laws governing, among other things, the generation, storage, use and transportation of hazardous materials and emissions or discharges into the ground, air or water. The company is or may become a party to proceedings brought under various federal laws including the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA), commonly known as Superfund, the Resource Conservation and Recovery Act, the Clean Water Act, the Clean Air Act and similar state or foreign laws. These proceedings seek to require the owners or operators of contaminated sites, transporters of hazardous materials to the sites and generators of hazardous materials disposed of at the sites to clean up the sites or to reimburse the government for cleanup costs. In most cases, there are other potentially responsible parties that may be liable for remediation costs. In these cases, the government alleges that the defendants are jointly and severally liable for the cleanup costs; however, these proceedings are frequently resolved so that the allocation of cleanup costs among the parties more closely reflects the relative contributions of the parties to the site contamination. The company’s potential liability varies greatly from site to site. For some sites, the potential liability is de minimis and for others the costs of cleanup have not yet been determined. Accruals for estimated losses from environmental remediation obligations generally are recognized no later than completion of the remedial feasibility study and are adjusted as further information develops or circumstances change. Costs of future expenditures for environmental remediation obligations are not discounted to their present value. Recoveries of environmental remediation costs from other parties are recorded as assets when their receipt is deemed probable. The company believes that the proceedings and claims described above will likely be resolved over an extended period of time. While it is not feasible to predict the outcome of these proceedings, based upon the company’s experience, current information and applicable law, the company does not expect these proceedings to have a material adverse effect on its financial condition and/or liquidity. However, one or more of the proceedings could be material to the company’s business and/or results of operations.

The company regularly monitors and evaluates the status of product liability and other legal matters, and may, from time-to-time, engage in settlement and mediation discussions taking into consideration developments in the matters and the risks and uncertainties surrounding litigation. These discussions could result in settlements of one or more of these claims at any time.

 

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Item 1A. Risk Factors

There have been no material changes to the risk factors disclosed in Part I, Item 1A. in Bard’s 2014 Annual Report on Form 10-K.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

The following table provides information with respect to the shares of the company’s common stock repurchased during the quarter ended June 30, 2015:

 

     Issuer Purchases of Equity Securities  

Period

   Total
Number
of Shares
Purchased (1)
     Average
Price
Paid
Per Share
     Total Number
of Shares
Purchased as
Part of Publicly
Announced
Programs(2)
     Maximum
Approximate
Dollar Value of
Shares
that May Yet
Be Purchased
Under Plans or
Programs(2)
 

April 1 – April 30, 2015

     81,161       $ 166.39         80,000       $ 177,619,746   

May 1 – May 31, 2015

     114,053         168.17         113,583         158,519,098   

June 1 – June 30, 2015

     4,841         170.02         —           658,519,098   
  

 

 

    

 

 

    

 

 

    

 

 

 

Total

  200,055    $ 167.49      193,583    $ 658,519,098   
  

 

 

    

 

 

    

 

 

    

 

 

 

 

(1) Includes 6,472 shares that the company repurchased during the three month period ended June 30, 2015 that were not part of the publicly announced share repurchase authorization. These shares were purchased from employees to satisfy tax withholding requirements on the vesting of restricted shares/units from equity-based awards.
(2) On June 11, 2014, the company announced that its Board of Directors had authorized the repurchase of up to $500 million of common stock of the company. On June 10, 2015, the Board of Directors authorized the repurchase of up to an additional $500 million of common stock.

Item 5. Other Information

The company’s policy governing transactions in its securities by the company’s directors, executive officers and other specified employees permits such persons to adopt trading plans pursuant to Rule 10b5-1 of the Exchange Act. From time-to-time, the company’s executive officers have established trading plans relating to the company’s common stock under Rule 10b5-1, and the company anticipates additional trading plans may be established in the future. The company currently discloses details regarding individual trading plans on its website.

Item 6. Exhibits

 

Number

  

Description

  12.1    Computation of Ratio of Earnings to Fixed Charges*
  31.1    Rule 13a-14(a) / 15d-14(a) Certification of Chief Executive Officer*
  31.2    Rule 13a-14(a) / 15d-14(a) Certification of Chief Financial Officer*
  32.1    Section 1350 Certification of Chief Executive Officer (furnished herewith)
  32.2    Section 1350 Certification of Chief Financial Officer (furnished herewith)
101.INS    XBRL Instance Document*
101.SCH    XBRL Taxonomy Extension Schema Document*
101.CAL    XBRL Taxonomy Extension Calculation Linkbase Document*
101.DEF    XBRL Taxonomy Extension Definition Linkbase Document*
101.LAB    XBRL Taxonomy Extension Label Linkbase Document*
101.PRE    XBRL Taxonomy Extension Presentation Linkbase Document*

 

* Filed herewith.

 

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

    C. R. BARD, INC.
        (Registrant)
Date: July 24, 2015      
     

/s/    CHRISTOPHER S. HOLLAND        

     

Christopher S. Holland

Senior Vice President and

Chief Financial Officer

     

/s/    FRANK LUPISELLA JR.        

     

Frank Lupisella Jr.

Vice President and Controller

 

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INDEX TO EXHIBITS

 

Number

  

Description

  12.1    Computation of Ratio of Earnings to Fixed Charges
  31.1    Rule 13a-14(a) / 15d-14(a) Certification of Chief Executive Officer
  31.2    Rule 13a-14(a) / 15d-14(a) Certification of Chief Financial Officer
  32.1    Section 1350 Certification of Chief Executive Officer (furnished herewith)
  32.2    Section 1350 Certification of Chief Financial Officer (furnished herewith)
101.INS    XBRL Instance Document
101.SCH    XBRL Taxonomy Extension Schema Document
101.CAL    XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF    XBRL Taxonomy Extension Definition Linkbase Document
101.LAB    XBRL Taxonomy Extension Label Linkbase Document
101.PRE    XBRL Taxonomy Extension Presentation Linkbase Document

 

37



EXHIBIT 12.1

C. R. BARD, INC. AND SUBSIDIARIES

Exhibit 12.1 - Computation of Ratio of Earnings to Fixed Charges

 

     Six Months
Ended
June 30,
2015
     Years Ended December 31,  
        2014      2013     2012     2011     2010  
(dollars in millions)                                       

Earnings from operations before taxes

   $ 243.8       $ 445.8       $ 1,213.4      $ 732.4      $ 510.8      $ 717.7   

Add (Deduct):

              

Fixed charges

     26.6         52.9         52.4        46.1        42.7        18.4   

Undistributed earnings of equity investments

     1.3         0.3         (1.0     (9.6     (3.8     (3.6
  

 

 

    

 

 

    

 

 

   

 

 

   

 

 

   

 

 

 

Earnings available for fixed charges

$ 271.7    $ 499.0    $ 1,264.8    $ 768.9    $ 549.7    $ 732.5   
  

 

 

    

 

 

    

 

 

   

 

 

   

 

 

   

 

 

 

Fixed charges:

Interest, including amounts capitalized(1)

$ 22.5    $ 44.8    $ 45.0    $ 39.6    $ 36.4    $ 12.7   

Proportion of rent expense deemed to represent interest factor

  4.1      8.1      7.4      6.5      6.3      5.7   
  

 

 

    

 

 

    

 

 

   

 

 

   

 

 

   

 

 

 

Fixed charges

$ 26.6    $ 52.9    $ 52.4    $ 46.1    $ 42.7    $ 18.4   
  

 

 

    

 

 

    

 

 

   

 

 

   

 

 

   

 

 

 

Ratio of earnings to fixed charges

  10.21      9.43      24.14      16.68      12.87      39.81   
  

 

 

    

 

 

    

 

 

   

 

 

   

 

 

   

 

 

 

 

(1)  Interest related to unrecognized tax benefits is included as income tax expense and not included in fixed charges.

 

38



EXHIBIT 31.1

Certification of Chief Executive Officer

I, Timothy M. Ring, certify that:

 

  1. I have reviewed this quarterly report on Form 10-Q of C. R. Bard, Inc.;

 

  2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

  3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

  4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

a) designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

b) designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

c) evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

d) disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

  5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

a) all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: July 24, 2015

/s/ Timothy M. Ring

Timothy M. Ring
Chief Executive Officer

 

39



EXHIBIT 31.2

Certification of Chief Financial Officer

I, Christopher S. Holland, certify that:

 

  1. I have reviewed this quarterly report on Form 10-Q of C. R. Bard, Inc.;

 

  2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

  3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

  4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

a) designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

b) designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

c) evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

d) disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

  5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

a) all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: July 24, 2015

/s/ Christopher S. Holland

Christopher S. Holland
Senior Vice President and Chief Financial Officer

 

40



EXHIBIT 32.1

SECTION 1350 CERTIFICATIONS

CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350,

AS ADOPTED PURSUANT TO SECTION 906 OF THE

SARBANES-OXLEY ACT OF 2002

In connection with the quarterly report of C. R. Bard, Inc. on Form 10-Q for the period ended June 30, 2015, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Timothy M. Ring, Chairman and Chief Executive Officer of C. R. Bard, Inc., certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:

 

  1. the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

 

  2. the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of C. R. Bard, Inc.

 

/s/ Timothy M. Ring

Name: Timothy M. Ring
Date: July 24, 2015

 

41



EXHIBIT 32.2

SECTION 1350 CERTIFICATIONS

CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350,

AS ADOPTED PURSUANT TO SECTION 906 OF THE

SARBANES-OXLEY ACT OF 2002

In connection with the quarterly report of C. R. Bard, Inc. on Form 10-Q for the period ended June 30, 2015, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Christopher S. Holland, Senior Vice President and Chief Financial Officer of C. R. Bard, Inc., certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:

 

  1. the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

 

  2. the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of C. R. Bard, Inc.

 

/s/ Christopher S. Holland

Name: Christopher S. Holland
Date: July 24, 2015

 

42

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